Actively Recruiting
Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer
Led by Peking Union Medical College Hospital · Updated on 2024-04-12
40
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of cardonilizumab injection combined with TKI in second-line treatment of advanced hepatocellular carcinoma. The main questions it aims to answer are: * Objective response rate (ORR) for evaluation * Disease Control Rate (DCR); Duration of relief (DoR); Progression free survival (PFS); Total survival time (OS); Safety。
CONDITIONS
Official Title
Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed hepatocellular carcinoma or cirrhosis meeting AASLD clinical diagnostic criteria
- Age 18 to 75 years old
- ECOG physical status score 0 or 1
- BCLC stage C not suitable for surgery or local treatment, or stage B progressing after such treatments
- Progression or intolerance after at least one prior systemic antitumor therapy for hepatocellular carcinoma
- At least one measurable untreated lesion or one with clear progression after local treatment
- Child-Pugh liver function level A
- Any toxicity from prior treatment resolved to baseline or stable except hair loss
You will not qualify if you...
- Fibrolamellar, sarcomatoid hepatocellular carcinoma or other histologically confirmed components
- History of hepatic encephalopathy
- History of liver transplantation
- Clinically significant pericardial or pleural effusion needing drainage
- Clinically significant ascites detected by exam or requiring drainage
- Co-infection with HBV and HCV (except negative HCV RNA with prior HCV infection)
- Central nervous system or meningeal metastasis
- Bleeding from esophageal or fundus varices due to portal hypertension within 6 months
- Severe varicose veins (grade 3) per gastroscopy within 6 months
- Any bleeding events or signs of bleeding within 4 weeks before starting treatment at grade 3 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)
Beijing, Beijing Municipality, China, 100730
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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