Actively Recruiting
Efficacy and Safety of PD-L1 Antibody Combined With Bevacizumab and Hepatic Arterial Infusion Chemotherapy in Advanced Unresectable Hepatocellular Carcinoma With Extrahepatic Metastases
Led by West China Hospital · Updated on 2024-12-19
36
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment for patients with advanced hepatocellular carcinoma (HCC) who have cancer spread outside the liver and cannot have surgery. This phase II trial focuses on safety and effectiveness of a PD-L1 antibody combined with bevacizumab and hepatic arterial infusion chemotherapy (HAIC). The study aims to improve outcomes for these patients, who currently have limited treatment options. Participants will receive intravenous PD-L1 antibody at 1200 mg and bevacizumab at 15 mg/kg every three weeks. They will also undergo up to six cycles of HAIC-FOLFOX chemotherapy, which includes oxaliplatin, leucovorin, and fluorouracil delivered via hepatic artery infusion. After completing HAIC, treatment with PD-L1 antibody and bevacizumab continues until the disease progresses, unacceptable side effects occur, or up to 24 months. During the study, tumor assessments will be done every nine weeks for the first 48 weeks, then every 12 weeks thereafter. Safety, disease response, progression, survival, and quality of life will be monitored. The primary measure is the objective response rate, while secondary measures include disease control, duration of response, progression-free survival, overall survival, and safety. The study plans to enroll 36 patients from October 2024 through July 2027.
CONDITIONS
Brief 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 or clinical diagnosis by HCC criteria
- Radiologically confirmed extrahepatic metastases with unresectable disease
- No prior PD-L1 antibody or bevacizumab treatment
- Age between 18 and 75 years
- ECOG Performance Status of 0 or 1
- Child-Pugh Class A or B7 liver function
- Able to comply with study protocol requirements
- At least one measurable or evaluable lesion per RECIST v1.1
- Adequate organ and bone marrow function including neutrophil count ≥1.5 x10^9/L, platelet count ≥75 x10^9/L, hemoglobin ≥9.0 g/dL
- Total bilirubin ≤2 times upper limit of normal
- ALT and AST ≤5 times upper limit of normal
- Serum creatinine ≤1.5 times upper limit of normal or creatinine clearance ≥50 mL/min
- Urine protein less than 2+ by dipstick
- APTT and INR ≤1.5 times upper limit of normal
- Normal cardiac enzymes
- Normal thyroid function or on stable replacement therapy
- Life expectancy of at least 12 weeks
- Effective contraception for participants of childbearing potential during treatment and for 6 months after last dose
You will not qualify if you...
- Severe liver disease complications (severe portal hypertension bleeding, infection, hepatic encephalopathy)
- Prior systemic anti-tumor therapy for HCC
- Other malignancy within past 5 years except treated non-melanoma skin cancer or carcinoma in situ
- Current participation in other interventional clinical trials
- Systemic treatment with Chinese herbal medicine or immunomodulators within 2 weeks before first dose
- Active autoimmune disease requiring systemic treatment within past 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
- Incomplete recovery from prior treatment toxicities
- Known HIV infection
- Untreated active hepatitis B infection
- Active hepatitis C infection
- Live vaccine within 30 days before first dose
- Pregnancy or breastfeeding
- Serious or uncontrolled systemic diseases including significant cardiac arrhythmias, unstable angina, heart failure class ≥2, recent arterial thrombosis, uncontrolled hypertension, interstitial lung disease, tuberculosis, systemic infections, diverticulitis or gastrointestinal obstruction, uncontrolled diabetes, significant proteinuria, psychiatric disorders affecting compliance
- Any condition interfering with study participation or result interpretation
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 24 months
Participants receive PD-L1 antibody and Bevacizumab intravenously every 3 weeks combined with up to 6 cycles of hepatic arterial infusion chemotherapy (HAIC-FOLFOX). After HAIC, PD-L1 antibody and Bevacizumab continue until disease progression, unacceptable toxicity, or up to 24 months of treatment.
Every 3 weeks for infusions; tumor assessments every 9 weeks for the first 48 weeks, then every 12 weeks thereafter
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
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