Actively Recruiting
Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy as First-Line Treatment for Advanced Hepatocellular Carcinoma: A Randomized, Controlled, Open-Label, Multicenter Phase III Study
Led by Linhui Peng ยท Updated on 2025-12-16
326
Participants Needed
1
Research Sites
156 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the use of Camrelizumab and Apatinib, with or without intravenous FOLFOX chemotherapy, as a first-line treatment for advanced hepatocellular carcinoma (HCC), a type of liver cancer. This phase III multicenter randomized study aims to compare these treatment approaches in patients whose cancer is advanced and unsuitable for surgery or local therapies, or who have progressed after such treatments. The study includes two treatment groups: one receiving a combination of infusional mFOLFOX7 chemotherapy plus Camrelizumab and Apatinib, and the other receiving Camrelizumab and Apatinib alone. The chemotherapy regimen involves specific doses of oxaliplatin and fluorouracil administered in cycles, while Camrelizumab is given by infusion every 21 days and Apatinib is taken orally daily. Chemotherapy is given for up to six cycles, and treatments continue in 21-day cycles. Participants will be monitored over several years for outcomes including progression-free survival and overall survival, with assessments up to approximately three to five years. Various secondary outcomes related to tumor response, disease control, and safety are also tracked. The study involves regular imaging scans, laboratory tests, and clinical evaluations to measure treatment effects and side effects. Participation may last for multiple years, including follow-up periods to assess long-term outcomes and safety.
CONDITIONS
Brief 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
- Histopathology, cytology, or clinical diagnosis of hepatocellular carcinoma (HCC)
- BCLC stage B or C HCC not suitable for curative surgery or local therapies, or progressed after such treatments
- Completed local therapy at least 4 weeks before baseline scan (2 weeks if palliative radiotherapy)
- No prior systemic treatment for HCC
- At least one measurable lesion by RECIST 1.1 criteria on CT/MRI
- Child-Pugh liver function Grade A or better B (score 7)
- ECOG performance status 0 to 2
- Expected survival of at least 12 weeks
- Normal major organ function meeting specific blood count and biochemistry requirements within 7 days before treatment
- Active hepatitis B patients must receive anti-HBV therapy and continue throughout the study; HCV RNA-positive must receive antiviral therapy with controlled liver function
- Women of childbearing potential must have negative pregnancy test, not be breastfeeding, and agree to contraception during and 6 months post-study; men must agree to contraception during and 6 months post-study
You will not qualify if you...
- Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, fibrolamellar carcinoma, or other active malignancies within 5 years (except certain treated localized tumors)
- Prior or planned organ or allogeneic hematopoietic stem cell transplantation
- Moderate to severe ascites requiring puncture or 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 abscess within 6 months
- Known bleeding disorders or thrombophilia
- Recent use of certain antiplatelet medications within 10 days before treatment
- Thrombotic or embolic events within 6 months
- Uncontrolled cardiac conditions including heart failure, unstable angina, recent myocardial infarction, significant arrhythmias, or poorly controlled hypertension
- Hypertension not controlled by medication or history of hypertensive crises
- Major vascular disease within 6 months
- Severe non-healing wounds, active ulcers, or untreated fractures
- Major surgery within 4 weeks before treatment or expected during study
- Inability to swallow pills or malabsorption
- History or signs of gastrointestinal obstruction within 6 months
- Unexplained intra-abdominal gas
- Central nervous system metastases or history of hepatic encephalopathy
- Active or history of interstitial lung disease or pneumonia requiring steroids; active tuberculosis
- Active or history of autoimmune diseases that may relapse, except controlled conditions
- Use of immunosuppressants or systemic steroids within 14 days before treatment
- Severe infection within 4 weeks before treatment or recent therapeutic antibiotics
- Congenital or acquired immunodeficiency (e.g., HIV)
- Coinfection with hepatitis B and C
- Prior treatment with anti-PD-1, PD-L1 therapies, or apatinib
- Recent live attenuated vaccination or investigational drug use
- Other factors that may affect study results or safety, such as alcoholism, drug abuse, severe illnesses, psychiatric disorders, or significant lab abnormalities
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 18 weeks for chemotherapy cycles (6 cycles) plus ongoing immunotherapy and apatinib until disease progression or unacceptable toxicity
Participants receive either infusional mFOLFOX7 plus Camrelizumab and Apatinib or Camrelizumab and Apatinib alone as first-line treatment for advanced hepatocellular carcinoma.
Visits every 3 weeks during treatment cycles
Duration - Up to approximately 3 years
Participants are monitored for progression-free and overall survival, as well as long-term treatment safety and response for up to 3 years.
Periodic visits for assessments during follow-up
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
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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