Treatment for advanced liver cancer using new drug combinations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of SHR-8068 combined with Adebrelimab and Bevacizumab compared to Sintilimab combined with Bevacizumab for patients with advanced hepatocellular carcinoma (HCC). It aims to determine which combination provides better outcomes as a first-line treatment for this aggressive form of liver cancer. Participants must have unresectable locally advanced or metastatic HCC and meet specific health criteria. The study will assess the efficacy based on measurable lesions and overall patient survival.

Why it matters

Who can join: the full rules

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.

Where it's running

• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Xin Shi
• Email: xin.shi.xs3@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.