Study of ThermoDox With Standardized Radiofrequency Ablation (RFA) for Treatment of Hepatocellular Carcinoma (HCC)

NCT02112656 | Completed Phase 3 Results DMC

• 1 other identifier: 104-13-302
• Study Type: interventional
• Target: 554
• Locations: 14 countries
• Sites: 61

Brief Summary

The purpose of this study is to determine whether ThermoDox, a thermally sensitive liposomal doxorubicin, is effective in the treatment of non-resectable hepatocellular carcinoma when used in conjunction with standardized radiofrequency ablation (sRFA).

Conditions

Hepatocellular Carcinoma

Keywords

Carcinoma; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Doxorubicin; Antibiotics, Antineoplastic; Antineoplastic Agents; Therapeutic Uses; Pharmacologic Actions

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival is defined as the time (in months) from the date of randomization to the death from any cause or the end of the study.

  All subjects to be contacted every 3 months after radiological progression for vital status reporting. Subjects were followed for OS up to 68 months from randomization.

Secondary Outcomes (1)

• Progression-free Survival (PFS)

  CT or MRI scan (Chest, Abdomen, Pelvis) done at Baseline and Day 28. Additional imaging done at months 5, 9, 13, 17, 21, 25, then every 6 months until disease progression is seen. Study subjects were followed up to 63 months after randomization.

Study Arms (2)

ThermoDox 50 mg/m2

EXPERIMENTAL

ThermoDox plus standardized RFA using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm

Drug: ThermoDox

Dummy infusion

PLACEBO COMPARATOR

standardized RFA alone using standardized treatment dwell time for solitary HCC lesions ≥ 3.0 cm to ≤ 7.0 cm

Drug: Dummy infusion

Interventions

ThermoDox DRUG

Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion

Also known as: Lyso-Thermosensitive Liposomal Doxorubicin (LTLD)

ThermoDox 50 mg/m2

Dummy infusion DRUG

Sodium Chloride 0.9% or 5% Dextrose (D5W), Single 30 minute intravenous infusion

Also known as: Placebo

Dummy infusion

Eligibility Criteria

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

You may qualify if:

• Male or female ≥ 18 years of age.
• Diagnosed with a single HCC lesion ≥ 3.0 cm but ≤ 7.0 cm in maximum diameter based on diagnosis at screening.
• Subjects meeting the American Association for the Study of Liver Disease (AASLD) criteria may be randomized without a biopsy, but will undergo a biopsy during the RFA procedure unless contraindicated or unattainable.
• Subjects not meeting the AASLD criteria for HCC will need a biopsy to confirm HCC prior to randomization.
• Be an appropriate candidate for receiving RFA as a medically indicated treatment as evaluated by the following factors:
• The position and accessibility of the target lesion allows for the safe administration of multiple ablation cycles or deployments to achieve a probe dwell time of ≥ 45 minutes.
• Not a candidate for surgical resection according to the local guidelines for resection and in the Investigator's judgment.
• Child-Pugh Class A without either current encephalopathy or ascites.
• Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
• Eastern Cooperative Oncology Group (ECOG) performance status 0.
• Willing to sign an informed consent form, indicating awareness of the investigational nature of this study that is in keeping with the policies of the institution.

You may not qualify if:

• Is scheduled for liver transplantation
• Expected ablation volume \> 30% of total liver volume or removal of 3 hepatic segments
• More than 1 lesion identified during baseline.
• Have previously received therapeutic treatment for HCC outside the study protocol or is expected to receive concomitant HCC treatment prior to PFS event.
• Have serious medical illnesses including, but not limited to, congestive heart failure, myocardial infarction or cerebral vascular accident within the last six months, or life threatening cardiac arrhythmias.
• Have previously received any anthracycline outside the protocol
• Have extrahepatic metastasis.
• Have portal or hepatic vein tumor invasion/thrombosis.
• Have body temperature \>101ºF (38.3ºC) immediately prior to study treatment.
• Baseline laboratories (repeat lab tests are permitted to evaluate eligibility during the Screening Period. Lab results must be within protocol range prior to study treatment.)
• Absolute neutrophil count \< 1500/mm3
• Platelet count \< 75,000/mm3
• Hgb \< 10.0 g/dL (unless the hemoglobin value has been stable, the subject is cardiovascularly stable, asymptomatic and judged able to withstand the RFA procedure) Note: If clinically indicated, subjects may receive platelets or packed red blood cell (RBC) transfusions and be re-evaluated after condition is treated.
• Baseline Chemistry
• Serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤25.0 mL/min.

Sponsors & Collaborators

• Imunon: lead

Study Sites (61)

UCLA Department of Medicine

Los Angeles, California, 90095, United States

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

Mengchao Hepatobiliary Hospital of Fujian Medicatl University

Fuzhou, Fujian, 350005, China

Location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Cancer Hospital, School of Oncology, Peking

Beijing, 100036, China

Location

302 Military Hospital of China

Beijing, 100039, China

Location

Beijing Hospital of the Ministry of Health

Beijing, 100730, China

Location

Chinese PLA General Hospital

Beijing, China

Location

West China Hospital of Sichuan University

Chengdu, 610041, China

Location

The Second Hospital of Dalian Medical University

Dalian, 116023, China

Location

Guangdong General Hospital

Guangdong, 510080, China

Location

Hunan Cancer Hospital

Hunan, 410013, China

Location

The First Hospital of Jilin University

Jilin, 130021, China

Location

Zhongshan Hospital, Fudan University

Shanghai, 200032, China

Location

The Sixth People's Hospital of Shenyang

Shenyang, 110006, China

Location

The 3rd Hospital of Tianjing

Tianjin, 300170, China

Location

The First Hospital of Zhejiang

Zhejiang, 310013, China

Location

Zhejiang Cancer Hospital

Zhejiang, 310022, China

Location

Institut für Diagnostische und Radiologische Therapie del Uniklinik Frankfurt

Frankfurt, Germany

Location

Universitaetsklinikum des Saarlandes, Klik fuer Allgemeine Chirurgie, Viszeral-, Gefaess und Kinderchirurgie

Homburg, 66421, Germany

Location

Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik (Gastroenterologie)

München, Germany

Location

Universitätsklinikum Regensburg, Institut für Röntgendiagnostik

Regensburg, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Cisanello Hospital, Division of Diagnostic Imaging and Intervention

Pisa, Italy

Location

Department of Radiological Sciences and Bioimaging Catholic University of Rome, "A. Gemelli" Hospital

Rome, Italy

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Chinese General Hospital and Medical Center

Manila, 1003, Philippines

Location

St. Lukes Medical Center

Quezon City, 1112, Philippines

Location

Cardinal Santos Medical Center

San Juan City, 1503, Philippines

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Pusan National University Hospital

Busan, 602-739, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Kyungpook National University Medical Center

Daegu, 702-210, South Korea

Location

Inha University Hospital

Incheon, 400-711, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, 137-701, South Korea

Location

Hospital Madrid Norte Sanchinarro

Madrid, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung City, 833, Taiwan

Location

Taipei Medical University-Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

Taichung Veteran General Hospital

Taichung, 407, Taiwan

Location

National Cheng Kung University (NCKU) Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan District, 333, Taiwan

Location

National Taiwan University Hospital, Yun-Lin Branch

Yuanlin, 640, Taiwan

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Thammasat University Hospital

Pathum Thani, 12120, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Bach Mai Hospital

Hà Nội, Dong Da District, Vietnam

Location

108 Military Central Hospital

Hà Nội, Hai Ba Trung District, Vietnam

Location

Hue Central Hospital

Huế, Vin Ninh Ward, Vietnam

Location

Bach Mai Hospital (Hepato-gastroenterology Department)

Hanoi, Vietnam

Location

Can Tho Oncology Hospital

Hanoi, Vietnam

Location

National Cancer Hospital

Hanoi, Vietnam

Location

Viet Duc University Hospital

Hanoi, Vietnam

Location

People's Hospital 115

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Imunon, Inc.

clinical@imunon.com

(609) 896-9100

Study Officials

• Ricardo Lencioni, MD

  University of Pisa

  STUDY CHAIR

• Ronnie Tung Ping Poon, MD

  Hong Kong University

  STUDY CHAIR

• Chen Min Hua, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: April 10, 2014
• First Posted: April 14, 2014
• Study Start: June 1, 2014
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Locations

IT (2); TH (5); PH (3); KR (8); US (1); ES (2); HK (1); CN (17); SG (1); VN (8); TW (7); CA (1); MY (1); DE (4)