Actively Recruiting
Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-11-20
20
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma
CONDITIONS
Official Title
Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before enrollment
- Age between 17 and 79 years, male or female
- Histologically or cytologically confirmed advanced hepatocellular carcinoma or clinical diagnosis per American Association of Liver Diseases criteria
- Previous progression or intolerance after targeted therapy, immunotherapy, or conventional therapy including TKI, ICI, chemotherapy, VEGF monoclonal antibody, or combinations
- At least 2 weeks since last systemic therapy with recovery of treatment-related adverse events to Grade 1 or less (except alopecia)
- Child-Pugh liver function grade A or good grade B (score ≤7) within 7 days before first dose
- Stage B or C by BCLC or Stage III by CNLC
- At least one measurable target lesion per mRECIST v1.1 within 4 weeks before first dose
- Adequate organ function without blood transfusion or supportive treatments within 14 days before starting study drug
- For HBV positive patients, HBV-DNA below specified limits or receiving antiviral therapy; HCV negative or receiving antiviral therapy with controlled liver enzymes
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Willingness to use contraception during the trial; females of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Tumors must be CD20 positive with scattered, non-aggregated distribution
You will not qualify if you...
- Known hepatocholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma
- History of hepatic encephalopathy within 6 months before first dose
- Portal hypertension with bleeding risk or variceal bleeding within 6 months before first dose
- Symptomatic brain or meningeal metastases unless treated >3 months with stable symptoms and no progression within 4 weeks
- HIV infection, active tuberculosis, or other uncontrolled active infections
- Major surgery within 4 weeks before enrollment or bone marrow/open/intracranial biopsy within 7 days before screening
- Other active malignant tumors within past 5 years except certain localized skin or cervical cancers
- History of severe allergy to monoclonal antibodies or study drug components
- Pregnant or breastfeeding women
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
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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