Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection

NCT04682210 | Unknown Phase 3

• 1 other identifier: B2020-280-01
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection

Conditions

HCC; Adjuvant Therapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival (RFS)

  RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death due to any cause (whichever occurs first).

  up to 36 months after randomization

Secondary Outcomes (5)

• Overall Survival (OS）

  up to 48 months after randomization

• RFS Rate at 12 and 24 months

  at 12 and 24 months after randomization

• OS Rate at 24 and 36 Months

  at 24 and 36 months after randomization

• TTR(time to recurrence)

  up to 36 months after randomization

• Adverse Events (AEs)

  up to 48 months after randomization

Study Arms (2)

Arm A

EXPERIMENTAL

sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W

Drug: Sintilimab; Drug: Bevacizumab

Arm B

NO INTERVENTION

Active surveillance

Interventions

Sintilimab DRUG

Sintilimab 200mg IV Q3W

Also known as: Tyvyt

Arm A

Bevacizumab DRUG

Bevacizumab 7.5mg/kg IV Q3W

Also known as: Byvasda

Arm A

Eligibility Criteria

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

You may qualify if:

• Patients with a first diagnosis of HCC who have undergone a curative resection
• Radiologic evidence of disease free ≥4 weeks after complete surgical resection
• Full recovery from surgical resection or post-operative transarterial chemoembolization before randomization
• Randomization needs to occur within 12 weeks of the date of surgical resection
• High risk for HCC recurrence as protocol defined
• Child-Pugh Score, Class A
• ECOG performance status 0 or 1
• No prior systemic anticancer therapy for HCC
• Adequate hematologic and organ function

You may not qualify if:

• Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
• Evidence of residual, recurrent, or metastatic disease at randomization
• History of hepatic encephalopathy or organ transplantation
• Patients who are in the waiting list for liver transplantation
• Patients with Vp4 portal vein thrombosis
• Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy
• Pregnant or lactating women

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

sintilimab; Bevacizumab

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Zhongguo Zhou

CONTACT

020-87343585; 54757370@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Department of Hepatobilliary Surgery

Study Record Dates

• First Submitted: December 20, 2020
• First Posted: December 23, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 23, 2020

Record last verified: 2020-12

Locations

CN (1)