drugset / Trial / NCT06496815

Donafenib Combined With Immunotherapy and Local Therapy for Unresectable Hepatocellular Carcinoma That Has Failed in Previous Therapy

NCT06496815

Phase 4 Not yet recruiting 32 enrolled Tongji Hospital
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if donafenib combined with or without immunotherapy and local therapy works to treat unresectable hepatocellular carcinoma that has failed in previous therapy. It will also learn about the safety of donafenib combined with immunotherapy and local therapy. The main questions it aims to answer are: The Objective Response Rate (mRecist) and Progression-Free Survival of the participants treated by donafenib combined with immunotherapy and local therapy. The disease control rate and overall survival of the participants treated by donafenib combined with immunotherapy and local therapy. The safety of donafenib combined with immunotherapy and local therapy in the participants. Participants will: Replace the original targeted drug with donafenib (0.2g bid), while continuing immunotherapy and local therapy as previous therapy (if have). The observation period was 1 year.

Timeline

Start
2024-08-01
Primary completion
2026-08-01
Completion
2027-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Donafenib Small molecule 0.2 g Oral