Advanced Hepatocellular Carcinoma
Conditions
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
Interventions
DRUGSHR-8068
SHR-8068: injection, 50 mg/10 mL, intravenous infusion
DRUGAdebrelimab
Adebrelimab: injection, 600 mg/12 mL, intravenous infusion
DRUGBevacizumab
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
DRUGSintilimab
Sintilimab: injection, 100 mg/10 mL, intravenous infusion
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is a randomized, controlled, open-label phase III study designed for efficacy evaluation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 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) | — |
| Overall survival (OS) | From randomization to death from any cause (whichever occurs first) (up to approximately 36 months) | OS is defined as the time from randomization to death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months) | ORR is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR), as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 |
| Duration of Response (DoR) | 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) | DOR is defined as the time 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) |
| Time to Progression (TTP) | 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)] | TTP is defined as the time from randomization to the until first evidence of disease progression as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 |
| The incidence, severity and relevance to investigational drugs of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAE v5.0 | From the ICF date until the end of the safety follow-up or initiation of new anti-tumor therapy (up to approximately 36 months) | — |
| Time to Response (TTR) | 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) | TTR is defined as time from the randomization of Complete Response (CR) or Partial Response (PR) by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 |
| Disease Control Rate (DCR) | 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) | DCR is defined as the proportion of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD), as determined by the Blinded Independ Review Committee (BIRC) according to RECIST v1.1 |
Countries
China
Contacts
Primary ContactXin Shi
Backup ContactYing Sun
Outcome results
None listed