NCT06496815

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-arm, prospective clinical study. 32 patients who had previously received a targeted drug in combination with or without immunotherapy, local therapy (transhepatic arterial embolization chemotherapy (TACE), hepatic arterial infusion chemotherapy (HAIC)) and had not received donafenib will be enrolled. The specific experimental protocol was to 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.

Conditions

• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Donafenib	Donafenib will be taken orally twice a day, 0.2g each time.
PROCEDURE	transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy	Eligible subjects will receive transhepatic arterial embolization chemotherapy or hepatic arterial infusion chemotherapy as previous (if have).
DRUG	PD-1,PD-L1	PD-1/PD-L1 will be used as previous (if have).

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2027-07-30
• First posted: 2024-07-11
• Last updated: 2024-07-11