Actively Recruiting
PD-L1 Antibody + Bevacizumab With Hepatic Arterial Infusion Chemotherapy for Advanced HCC
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
This is a single-arm, phase II clinical trial evaluating the safety and efficacy of PD-L1 antibody combined with bevacizumab and hepatic arterial infusion chemotherapy (HAIC) for patients with advanced unresectable hepatocellular carcinoma (HCC) with extrahepatic metastases. Study Population: Patients with advanced HCC who have: * Confirmed extrahepatic metastases * No prior PD-L1 or bevacizumab therapy * Age 18-75 years * Child-Pugh A or B7 liver function * ECOG performance status 0-1 Treatment Regimen: * PD-L1 antibody: 1200mg every 3 weeks * Bevacizumab: 15mg/kg every 3 weeks * HAIC with FOLFOX regimen: Up to 6 cycles * Treatment continues until disease progression or up to 24 months Primary Endpoint: -Objective Response Rate (ORR) Secondary Endpoints: * Disease Control Rate (DCR) * Duration of Response (DOR) * Progression-free Survival (PFS) * Overall Survival (OS) * Safety assessments * Quality of life measurements Study Design Details: * Single-arm study using Simon's two-stage design * First stage: 27 patients * Second stage: 9 additional patients if first stage shows efficacy * Total planned enrollment: 36 patients * Study duration: October 2024 - July 2027 This study aims to evaluate whether adding HAIC to PD-L1 inhibitor plus bevacizumab immunotherapy can improve outcomes for advanced HCC patients with extrahepatic spread, who currently have limited treatment options. The trial will assess both efficacy and safety of this combination approach.
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.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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