Clinical trial NCT06618664: Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Study of Anti CTLA-4 Antibody SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the First-line Treatment of Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized, controlled, open-label phase III study designed for efficacy evaluation.
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From Randomization to the first occurrence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
measure: Overall survival (OS)
timeFrame: From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: From randomization to the first occurrence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]
measure: Disease Control Rate (DCR)
timeFrame: From Randomization to the first occurrence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)
measure: Objective Response Rate (ORR)
timeFrame: From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)
measure: Duration of Response (DoR)
timeFrame: From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)
measure: Time to Response (TTR)
timeFrame: From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)
measure: The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0
timeFrame: From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 months)
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
Study officials:
References: