NCT06618664 A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
| NCT ID | NCT06618664 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Advanced Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 590 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 590 participants in total. It began in 2024-10-28 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
THis study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab or Atezolizumab combined with Bevacizumab for the first-line treatment of advanced HCC.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06618664 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06618664 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 590 participants.
Is NCT06618664 currently recruiting?
Yes, NCT06618664 is actively recruiting participants. Contact the research team at xin.shi.xs3@hengrui.com for enrollment information.
Where is the NCT06618664 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06618664 clinical trial?
NCT06618664 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 590 participants.
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