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Trial Title:
Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma
NCT ID:
NCT06618664
Condition:
Advanced Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study is a randomized, controlled, open-label phase III study designed for efficacy
evaluation.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-8068
Description:
SHR-8068: injection, 50 mg/10 mL, intravenous infusion
Arm group label:
SHR-8068 combined with Adebrelimab and Bevacizumab
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab: injection, 600 mg/12 mL, intravenous infusion
Arm group label:
SHR-8068 combined with Adebrelimab and Bevacizumab
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Bevacizumab: injection, 100 mg/4 mL, intravenous infusion
Arm group label:
SHR-8068 combined with Adebrelimab and Bevacizumab
Arm group label:
Sintilimab combined with Bevacizumab
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Sintilimab: injection, 100 mg/10 mL, intravenous infusion
Arm group label:
Sintilimab combined with Bevacizumab
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Contact:
Last name:
Lianxin Liu
Phone:
+86-13845159888
Email:
liulx@ustc.edu.cn
Contact backup:
Last name:
Shukui Qin
Phone:
+86-13905158713
Email:
qinsk@csco.org.cn
Start date:
October 30, 2024
Completion date:
December 31, 2030
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06618664
