Actively Recruiting
Efficacy and Safety Comparison Between Intensified Therapy and Conversion Therapy For Advanced HCC After Failure of First-line
Led by Sun Yat-sen University · Updated on 2026-03-30
80
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Although immunotherapy-based therapies (including targeted-immunotherapy or dual-immunotherapy protocols) have become the first-line standard treatment for advanced hepatocellular carcinoma (HCC), there remains a lack of high-level evidence to guide the selection of second-line therapies following progression in immune checkpoint inhibitors (ICIs). Additionally, direct comparative data are scarce for combination treatment modalities such as "continuation of the original first-line regimen with added agents" or "switching to agents with different mechanisms". To address this clinical need and explore novel second-line treatment strategies for advanced HCC, we plan to conduct an exploratory clinical trial to investigate the efficacy and safety comparison between intensified therapy (plus lenvatinib) and conversion therapy (regorafenib combined with PD-1 inhibitor) for advanced hepatocellular carcinoma after failure of fFirst-line bevacizumab plus sintilimab.
CONDITIONS
Official Title
Efficacy and Safety Comparison Between Intensified Therapy and Conversion Therapy For Advanced HCC After Failure of First-line
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hepatocellular carcinoma (HCC) based on histological or clinical criteria
- Classified as unresectable HCC after multidisciplinary assessment
- Have at least one tumor measurable by EASL criteria
- Child-Pugh liver function class A or B and ECOG Performance Status score 0-2
- Disease progression confirmed by CT/MRI after 2 or more cycles of first-line bevacizumab plus sintilimab
- Received 2 or more cycles of post-progression treatment with bevacizumab plus sintilimab, lenvatinib, or regorafenib combined with PD-1 inhibitors
- Age between 18 and 75 years
- Able to understand the study protocol and provide written informed consent
- Laboratory values: hemoglobin ≥8.5 g/dL, white blood cell count >2000/mm³, platelet count ≥75,000/mm³, absolute neutrophil count >1500/mm³, total bilirubin ≤30 µmol/L, serum albumin ≥30 g/L, AST and ALT ≤5 times upper limit of normal, serum creatinine ≤1.5 times upper limit of normal, INR ≤1.5, prothrombin time ≤18 seconds
- Have complete baseline, treatment, and follow-up data including imaging, labs, and clinical records
You will not qualify if you...
- Life expectancy less than 2 months
- Presence of intrahepatic cholangiocarcinoma, mixed hepatocellular-cholangiocarcinoma, or other non-HCC cancers
- Have active concurrent malignancy or severe comorbid conditions
- Received other anticancer therapies (chemotherapy, radiotherapy, surgery, or others) concurrently with first-line treatment
- Pregnancy or breastfeeding
- Known allergy to study drugs
- Significant gastrointestinal bleeding within 30 days before enrollment
- Refusal to comply with study or follow-up procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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