Actively Recruiting
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial
Led by Peking University Cancer Hospital & Institute · Updated on 2024-04-22
111
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining anti-PD-1/PD-L1 immunotherapy with anti-angiogenic drugs as a first treatment for people with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. This multicenter, randomized, open-label phase 2 clinical trial compares three treatment combinations to find the best approach for this serious condition. Participants receive one of three drug combinations. The first group gets Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally daily. The second group receives Adebrelimab 1200mg intravenously plus Bevacizumab 15mg/kg intravenously every 3 weeks. The third group is treated with Camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally daily. These treatments are given as first-line therapy, meaning they are the initial systemic treatment for advanced HCC. Throughout the study, participants are closely monitored for overall survival at 12 months and other outcomes such as response rates, disease control, duration of response, time to response, progression-free survival, and safety using standard criteria. The study lasts up to about 3 years, during which patients undergo regular assessments to track cancer progression, side effects, and overall health. This comprehensive monitoring helps researchers understand how well each treatment works and its safety profile.
CONDITIONS
Brief Title
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Locally advanced, metastatic, or unresectable hepatocellular carcinoma (HCC)
- No prior systemic therapy for HCC (herbal or traditional medicines with anti-cancer activity allowed)
- BCLC stage B or C, unsuitable for surgery or local therapy, or progressed after such therapies
- At least one measurable tumor lesion according to RECIST v1.1
- ECOG Performance Status of 0 or 1
- Child-Pugh liver function class A5 to B7
- Adequate organ function as determined by study requirements
You will not qualify if you...
- Diagnosis of hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or lamellar cell carcinoma
- Other active cancer within 5 years or simultaneously except HCC
- Moderate to severe ascites with symptoms
- Gastrointestinal bleeding history within 6 months or tendency to bleed
- Abdominal fistula, gastrointestinal perforation, or intraperitoneal abscess within 6 months
- Known bleeding or clotting disorders
- Thrombosis or thromboembolic events within 6 months
- Poorly controlled hypertension despite medication
- Factors preventing oral drug administration
- History of hepatic encephalopathy
- Brain metastasis currently or previously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive one of the study drug combinations involving intravenous and oral medications as first-line therapy for unresectable hepatocellular carcinoma.
Intravenous treatments every 2 or 3 weeks and daily oral medication; visit frequency varies with treatment schedule
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Jun Zhou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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