Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Sep 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatment combinations for patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC). Specifically, it compares a new treatment called SHR-8068 combined with Adebrelimab and Bevacizumab to another treatment combination of Sintilimab and Bevacizumab. The goal is to find out which combination works better as the first line of treatment for this serious condition.

To join this trial, participants need to be at least 18 years old and have been diagnosed with advanced HCC that cannot be surgically removed. They should not have received any prior treatment for HCC and must have a good performance status, meaning they can carry out daily activities with little to no issues. Participants will receive the assigned treatments and be monitored closely throughout the study. It's important to note that certain health conditions may prevent someone from participating, so potential volunteers should discuss their medical history with the trial team. Overall, this study aims to improve treatment options for individuals facing advanced liver cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able and willing to provide a written informed consent
• • 2. ≥ 18 years old, both male and female
• • 3. Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically
• • 4. At least one measurable lesion based on RECIST v1.1 criteria
• • 5. Barcelona clinic liver cancer: Stage B or C
• • 6. No previous systemic antitumor therapy for HCC
• • 7. ECOG PS of 0-1
• • 8. Child-Pugh score of A or B7
• • 9. Expected survival period ≥ 12 weeks
• • 10. Adequate organ function
• • 11. Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception
• Exclusion Criteria:
• • 1. Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma
• • 2. Patients with other malignancies currently or within the past 5 years
• • 3. With known severe allergic reactions to any other monoclonal antibodies
• • 4. Patients with known CNS metastasis or hepatic encephalopathy
• • 5. Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants
• • 6. Patients with symptomatic ascites or pleural effusion
• • 7. Patients with hypertension which cannot be well controlled by antihypertensives
• • 8. Uncontrolled cardiac diseases or symptoms
• • 9. Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs)
• • 10. Major vascular disease occurred in the 6 months before randomization
• • 11. Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization
• • 12. Major surgery within 28 days before randomization or expected to require major surgery during the study period
• • 13. Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC \> 15×109/L at baseline
• • 14. Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection
• • 15. Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period
• • 16. Patients with other potential factors that may affect the study results