Actively Recruiting
Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC
Led by Linhui Peng · Updated on 2025-12-16
326
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center randomized phase III clinical study of first-line Camrelizumab and Apatinib with or without intravenous FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma (HCC).
CONDITIONS
Official Title
Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older, male or female
- Volunteered and signed informed consent
- Confirmed diagnosis of hepatocellular carcinoma (HCC) by histopathology, cytology, or clinical diagnosis
- BCLC stage B or C HCC unsuitable for curative surgery or local therapies, or progressed after such treatments
- Completed local therapy at least 4 weeks before baseline scan (2 weeks if only palliative radiotherapy)
- No prior systemic treatment for HCC
- At least one measurable lesion per RECIST 1.1 criteria
- Child-Pugh liver function Grade A or better Grade B (score 7)
- ECOG performance status score 0-2
- Expected survival of at least 12 weeks
- Adequate major organ function within 7 days before study treatment start, including blood counts, liver and kidney function, coagulation, and urine protein
- Patients with active hepatitis B must receive antiviral therapy before and during study
- Hepatitis C RNA-positive patients must receive antiviral therapy with liver function not exceeding grade 1 elevation
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment, not be breastfeeding, and agree to contraception during and for 6 months after the study
- Men must agree to use contraception during and for 6 months after the study
You will not qualify if you...
- Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, fibrolamellar carcinoma, or other active malignancies within past 5 years except certain treated localized tumors
- Preparation for or prior organ/allogeneic hematopoietic stem cell transplantation
- Moderate to severe ascites requiring therapeutic drainage; uncontrolled pleural or pericardial effusion
- History of gastrointestinal bleeding within 6 months or high risk for bleeding
- Abdominal fistulas, gastrointestinal perforation, or intra-abdominal abscesses within 6 months
- Known bleeding disorders or thrombophilia
- Current or recent use of high-dose aspirin or other specified antiplatelet drugs
- Thrombotic or embolic events within 6 months
- Uncontrolled cardiac conditions including heart failure NYHA class II or above, unstable angina, recent myocardial infarction, serious arrhythmias, or poorly controlled hypertension
- Hypertension not controlled by medication or history of hypertensive crises
- Major vascular disease within 6 months
- Severe or non-healing wounds, active ulcers, untreated fractures
- Major surgery within 4 weeks prior or planned during study
- Inability to swallow pills or malabsorption
- History or signs of gastrointestinal obstruction within 6 months
- Unexplained intra-abdominal gas
- Past or present central nervous system metastases
- History of hepatic encephalopathy
- Current or past interstitial lung diseases or active tuberculosis
- Active or history of autoimmune diseases prone to relapse, with some exceptions
- Use of immunosuppressants or systemic steroids above 10 mg prednisone equivalent within 14 days
- Severe infection or recent antibiotics use within specified timeframes
- Congenital or acquired immunodeficiency
- Coinfection with hepatitis B and C
- Prior treatment with PD-1/PD-L1 inhibitors or apatinib
- Live attenuated vaccine use within 28 days before or planned during treatment
- Use of other investigational drugs within 28 days
- Other factors per investigator judgment that may affect study or patient safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
L
Linhui Peng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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