Status:
WITHDRAWN
A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Hepatocellular Carcinoma (HCC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the efficacy and safety of HLX10 + HLX04 vs Sorafenibas as the First-line Treatment in Patients with Locally ...
Eligibility Criteria
Inclusion
- Volunteer to participate in the clinical study;
- Aged ≥ 18 years and ≤ 75 years;
- Patients with histopathologically or cytologically diagnosed locally advanced or metastatic and/or unresectable HCC , or patients with clinically diagnosed HCC according to the diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD);
- Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B patients who are not candidates for radical surgery and/or locoregional therapy.
- Received no prior systemic HCC treatment (including chemotherapy, treatment with sorafenib, regorafenib, lenvatinib, or other small-molecule antiangiogenic agents);
- At least one measurable lesion by the IRRC (central radiography) as per RECIST v1.1
- Normal major organ functions as defined
Exclusion
- Patients with known hepatobiliary cell carcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma;
- History of hepatic encephalopathy;
- Patients with portal hypertension complicated with upper gastrointestinal hemorrhage, or esophageal/gastric fundal varices with the red color sign, or high hemorrhage risk investigated by the investigator within 6 months before the randomization. Subjects must receive endoscopic examinations to rule out high hemorrhage risk (e.g. red color sign and severe varices) before enrollment.
- Patients with portal vein invasion at the main portal branch (Vp4), inferior vena cava involvement, or right cardiac involvement of HCC based on imaging examination. Patients with portal vein invasion at the main portal branch but with unobstructed blood flow in the bilateral or unilateral branch can be enrolled;
- Central nervous system (CNS) or leptomeningeal metastases;
- Positive for both HBV-DNA and HCV-RNA;
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04465734
Start Date
November 15 2022
End Date
March 15 2024
Last Update
May 5 2022
Active Locations (1)
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1
Ethics committee of zhongshan hospital affiliated to fudan university
Shanghai, China