Actively Recruiting
Study of PD-L1 Antibody, Bevacizumab, and Hepatic Arterial Infusion Chemotherapy in Advanced Unresectable Hepatocellular Carcinoma with Spread Outside the Liver A Single-Arm Phase II Clinical Trial
Led by West China Hospital · Updated on 2024-12-19
36
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment using a PD-L1 antibody, bevacizumab, and hepatic arterial infusion chemotherapy (HAIC) in patients with advanced, unresectable hepatocellular carcinoma (HCC) that has spread beyond the liver. This phase II, single-arm study focuses on patients aged 18 to 75 years with confirmed extrahepatic metastases, good liver function (Child-Pugh A or B7), and good performance status (ECOG 0-1). The trial aims to improve outcomes for these patients who currently have limited treatment options by assessing the response rate and safety of this combined therapy. Participants receive intravenous PD-L1 antibody at 1200 mg every three weeks and bevacizumab at 15 mg/kg every three weeks. They also undergo up to six cycles of HAIC using the FOLFOX regimen, which includes oxaliplatin, leucovorin, and fluorouracil delivered through the hepatic artery every three weeks. Treatment continues until the disease progresses or for a maximum of 24 months. The study uses Simon's two-stage design, enrolling 27 patients initially and potentially 9 more if initial results are promising, with a total planned enrollment of 36 patients. During the study, participants have tumor assessments every 9 weeks for the first 48 weeks and every 12 weeks afterward up to 24 months or until disease progression. Researchers monitor objective response rate as the primary outcome, along with disease control rate, duration of response, progression-free survival, overall survival, safety, and quality of life. Participants undergo various evaluations including imaging, laboratory tests, and safety assessments throughout the treatment period and follow-up.
CONDITIONS
Official Title
PD-L1 Antibody + Bevacizumab With Hepatic Arterial Infusion Chemotherapy for Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC) or clinically diagnosed by HCC criteria
- Radiologically confirmed extrahepatic metastases with unresectable disease
- No prior treatment with PD-L1 antibody or bevacizumab
- Age between 18 and 75 years
- ECOG Performance Status of 0 or 1
- Child-Pugh Class A or B7 liver function
- Ability to comply with study protocol requirements
- At least one measurable or evaluable lesion by RECIST v1.1
- Adequate organ and bone marrow function including: Absolute neutrophil count ≥1.5×10^9/L Platelet count ≥75×10^9/L Hemoglobin ≥9.0 g/dL Total bilirubin ≤2× upper limit of normal (ULN) ALT and AST ≤5× ULN Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min Urine protein less than 2+ by dipstick APTT and INR ≤1.5× ULN Normal cardiac enzymes Normal thyroid function or stable thyroid replacement therapy
- Life expectancy of at least 12 weeks
- Effective contraception during treatment and for 6 months after last dose
You will not qualify if you...
- Severe complications from liver disease such as severe bleeding from portal hypertension, infection, or hepatic encephalopathy
- Prior systemic anti-tumor therapy for HCC
- Other malignancy within the last 5 years (except treated non-melanoma skin cancer or carcinoma in situ)
- Current participation in other interventional clinical trials
- Use of Chinese herbal medicine or immunomodulators within 2 weeks before first dose
- Active autoimmune disease requiring systemic treatment within 2 years
- Systemic corticosteroid therapy within 7 days before first dose
- Prior allogeneic organ or stem cell transplantation (except corneal)
- Known allergy to monoclonal antibodies or HAIC components
- Inadequate recovery from prior treatment toxicities
- Known HIV infection
- Untreated active hepatitis B infection
- Active hepatitis C infection
- Live vaccine administration within 30 days before first dose
- Pregnancy or breastfeeding
- Serious or uncontrolled systemic diseases including significant cardiac arrhythmias, unstable angina, heart failure class NYHA ≥2, recent arterial thrombotic events, uncontrolled hypertension, active lung disease, active tuberculosis, active infections, diverticulitis or gastrointestinal obstruction, uncontrolled diabetes, significant proteinuria, psychiatric disorders affecting compliance
- Any condition interfering with study participation or results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
Yiwen Qiu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here