Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

NCT03847428 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: D910DC000012023-507689-26-002018-004105-85
• Study Type: interventional
• Target: 908
• Locations: 23 countries
• Sites: 213

Brief Summary

A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

Conditions

Hepatocellular Carcinoma

Keywords

Early stage HCC; Durvalumab; Bevacizumab; Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival (RFS) for Arm A vs Arm C

  RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.

  Up to 49 months after first patient randomized

Secondary Outcomes (5)

• Recurrence-free survival (RFS) Arm B vs Arm C

  Up to 49 months after first patient randomized

• Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C

  No timeframe

• Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C

  At 24 and at 36 months

• Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C

  Up to 49 months after first patient randomized

• Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C

  Up to 49 months after first patient randomized

Study Arms (3)

Arm A

EXPERIMENTAL

Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)

Drug: Durvalumab; Drug: Bevacizumab

Arm B

EXPERIMENTAL

Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)

Drug: Durvalumab; Other: Placebo

Arm C

PLACEBO COMPARATOR

Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)

Other: Placebo

Interventions

Durvalumab DRUG

Durvalumab IV (intravenous)

Also known as: IMFINZI

Arm A; Arm B

Bevacizumab DRUG

Bevacizumab IV (intravenous)

Also known as: AVASTIN

Arm A

Placebo OTHER

Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking

Arm B; Arm C

Eligibility Criteria

• Age: 18 Years - 150 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
• Imaging to confirm disease-free status within 28 days prior to randomization
• ECOG 0-1 at enrolment
• Child-Pugh score of 5 or 6
• Adequate organ and marrow function.

You may not qualify if:

• Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
• Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
• History of hepatic encephalopathy within 12 months prior to randomization
• Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
• Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
• Active co-infection with HBV and HDV.
• Receipt of prior systemic anticancer therapy for HCC
• Those on a waiting list for liver transplantation

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (217)

Research Site

Birmingham, Alabama, 35233, United States

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Mobile, Alabama, 36604, United States

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Phoenix, Arizona, 85054, United States

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Costa Mesa, California, 92627, United States

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La Jolla, California, 92093-0698, United States

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Long Beach, California, 90806, United States

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Orange, California, 92868, United States

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Sacramento, California, 95817, United States

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Washington D.C., District of Columbia, 20007, United States

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Miami, Florida, 33176, United States

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Tampa, Florida, 33606, United States

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Honolulu, Hawaii, 96819, United States

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Chicago, Illinois, 60637, United States

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Westwood, Kansas, 66205, United States

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Louisville, Kentucky, 40206, United States

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Shreveport, Louisiana, 71103, United States

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Detroit, Michigan, 48201, United States

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Grand Rapids, Michigan, 49503, United States

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Rochester, Minnesota, 55905, United States

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Omaha, Nebraska, 68198, United States

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New Brunswick, New Jersey, 08903, United States

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Albuquerque, New Mexico, 87109, United States

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New York, New York, 10021, United States

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Stony Brook, New York, 11794, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27157, United States

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Cleveland, Ohio, 44106, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Spartanburg, South Carolina, 29303, United States

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Knoxville, Tennessee, 37916, United States

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Memphis, Tennessee, 38104, United States

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Dallas, Texas, 75216, United States

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Madison, Wisconsin, 53715, United States

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Kogarah, 2217, Australia

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Melbourne, 3004, Australia

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Nedlands, 6009, Australia

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Westmead, 2145, Australia

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Innsbruck, 6020, Austria

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Linz, 4010, Austria

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Sankt Pölten, 3100, Austria

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Florianópolis, 88034-000, Brazil

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Porto Alegre, 90020-090, Brazil

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Porto Alegre, 90035-003, Brazil

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Rio de Janeiro, 20231-050, Brazil

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Santa Maria, 97015-450, Brazil

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Santo André, 09060-870, Brazil

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São José do Rio Preto, 15090-000, Brazil

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Vitória, 29043-272, Brazil

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Hamilton, Ontario, L8V 5C2, Canada

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Kingston, Ontario, K7L 2V7, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Québec, Quebec, G1R 2J6, Canada

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Beijing, 100021, China

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Beijing, 100142, China

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Beijing, 100730, China

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Bengbu, 233004, China

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Changchun, 130021, China

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Changsha, 410013, China

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Chengdu, 610041, China

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Fuzhou, 350005, China

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Guangzhou, 510000, China

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Guangzhou, 510080, China

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Guangzhou, 510515, China

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Hangzhou, 310003, China

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Hangzhou, 310016, China

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Hangzhou, 310022, China

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Harbin, 150049, China

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Hefei, 230001, China

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Hohhot, 010010, China

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Nanjing, 2100008, China

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Nanjing, 210002, China

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Ningbo, 315100, China

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Shanghai, 200032, China

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Shanghai, 201114, China

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Shanghai, 201318, China

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Tianjin, 300170, China

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Ürümqi, 830000, China

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Wuhan, 430079, China

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Xi'an, 710061, China

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Zhengzhou, 450052, China

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Alexandria, 21131, Egypt

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Asyut, 71511, Egypt

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Cairo, 11451, Egypt

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Cairo, 11588, Egypt

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Cairo, 11796, Egypt

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Dakahlia, 35516, Egypt

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New Cairo, 11566, Egypt

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Shebeen El Kom, 32511, Egypt

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Amiens, 88054, France

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Angers, 49933, France

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Besançon, 25000, France

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Clichy, 92110, France

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Dijon, 21079, France

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Nantes, 44093, France

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Nice, 06200, France

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Paris, 75571, France

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Pessac, 33604, France

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Toulouse, 31059, France

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Tours, 37049, France

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Berlin, 13353, Germany

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Bonn, 53105, Germany

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Chemnitz, 09116, Germany

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Cologne, 50937, Germany

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Freiburg im Breisgau, 79106, Germany

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Heidelberg, 69120, Germany

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Leipzig, 04103, Germany

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Lübeck, 23538, Germany

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München, 81377, Germany

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Tübingen, 72076, Germany

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Hong Kong, 0000, Hong Kong

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Hong Kong, 150001, Hong Kong

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Hong Kong, 999077, Hong Kong

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Hong Kong, Hong Kong

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Kwai Chung, 999077, Hong Kong

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Shatin, 00000, Hong Kong

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Bangalore, 560027, India

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Bangalore, 560092, India

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Hyderabad, 500032, India

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Kolkata, 700160, India

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Mumbai, 400012, India

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New Delhi, 110017, India

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New Delhi, 110076, India

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New Delhi, 110085, India

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Bologna, 40138, Italy

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Milan, 20132, Italy

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Milan, 20162, Italy

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Naples, 80131, Italy

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Roma, 00168, Italy

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Tricase, Lecce, 73039, Italy

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Verona, 37134, Italy

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Bunkyō City, 113-8655, Japan

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Fukuoka, 810-8563, Japan

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Gifu, 500-8513, Japan

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Hiroshima, 734-8551, Japan

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Kōtoku, 135-8550, Japan

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Kumamoto, 860-8556, Japan

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Kurume-shi, 830-0011, Japan

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Kyoto, 606-8507, Japan

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Kyoto, 612-8555, Japan

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Matsuyama, 790-8524, Japan

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Mitaka-shi, 181-8611, Japan

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Musashino-shi, 180-8610, Japan

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Nagasaki, 852-8501, Japan

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Nagoya, 466-8560, Japan

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Nagoya, 467-8602, Japan

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Osaka, 534-0021, Japan

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Osaka, 541-8567, Japan

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Osaka, 543-8555, Japan

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Osakasayama-shi, 589-8511, Japan

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Sapporo, 006-8555, Japan

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Sapporo, 060-0033, Japan

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Sendai, 980-0872, Japan

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Shinagawa-ku, 142-8666, Japan

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Shinjuku-ku, 160-0023, Japan

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Shinjuku-ku, 162-8655, Japan

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Shiwa-gun, 028-3695, Japan

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Takasaki-shi, 370-0829, Japan

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Tsu, 514-8507, Japan

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Wakayama, 641-8510, Japan

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Yokohama, 241-8515, Japan

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Yokohama, 245-8575, Japan

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Lima, LIMA 31, Peru

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Lima, LIMA 34, Peru

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Lima, LIMA 41, Peru

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San Isidro, 27, Peru

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City of Muntinlupa, 1780, Philippines

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Manila, 1000, Philippines

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Pasig, 1605, Philippines

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Bydgoszcz, 85-796, Poland

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Gdansk, 80-952, Poland

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Poznan, 61-866, Poland

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Warsaw, 02-034, Poland

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Ponce, 00716, Puerto Rico

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Barnaul, 656049, Russia

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Moscow, 119421, Russia

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Moscow, 125284, Russia

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Obninsk, 249031, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197044, Russia

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Saint Petersburg, 197758, Russia

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Yekaterinburg, 620905, Russia

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Singapore, 119074, Singapore

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Singapore, 308433, Singapore

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Singapore, 329563, Singapore

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Busan, 49241, South Korea

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Daegu, 41944, South Korea

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Seoul, 03080, South Korea

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Seoul, 03722, South Korea

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Seoul, 05505, South Korea

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Seoul, 06351, South Korea

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Changhua, 500, Taiwan

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Tainan, 710, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 11217, Taiwan

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Taoyuan, 333, Taiwan

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Yunlin, 640, Taiwan

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Bangkok, 10210, Thailand

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Bangkok, 10300, Thailand

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Bangkok, 10330, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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Hat Yai, 90110, Thailand

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Khon Kaen, 40002, Thailand

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Pathum Thani, 12120, Thailand

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Ankara, 06100, Turkey (Türkiye)

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Ankara, 6200, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Malatya, 44100, Turkey (Türkiye)

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Hanoi, 100000, Vietnam

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Hanoi, 123, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Ho Chi Minh City, Vietnam

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Hochiminh, 70000, Vietnam

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MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

durvalumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jia Fan, PhD

  Liver Cancer Institute Zhongshan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

• Jennifer Knox, MD

  Solid Tumor Medical Oncology Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 20, 2019
• Study Start: April 29, 2019
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

TU (5); PR (1); DE (10); BR (8); PE (4); HK (6); PH (3); PL (4); VN (5); EG (8); SG (3); TH (8); RU (8); CN (28); IT (7); CA (6); US (34); FR (11); AU (3); TW (6); JP (31); KR (6); IN (8)