NCT05545124

Study of Donafenib Combined With Tislelizumab in the Adjuvant Treatment of Primary HCC With High Risk of Recurrence

Clinical Study of Donafenib Combined With Tislelizumab in the Adjuvant Therapy of High-risk Recurrence-risk Primary Hepatocellular Carcinoma After Radical Surgical Resection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the safety and preliminary efficacy of donafenib combined with tislelizumab in adjuvant therapy after radical surgical resection of primary hepatocellular carcinoma with high risk of recurrence.

Detailed description

This study is a single-center, single-arm, open-label clinical study. For HCC patients who the investigator believes can benefit from adjuvant treatment with donafenib combined with PD-1 monoclonal antibody, they will sign an informed consent form, and then start donafenib within 1-2 months after radical surgery (stable disease assessment or improvement). Adjuvant therapy with fenib combined with tislelizumab for 6 months, to explore the safety and efficacy of postoperative adjuvant therapy with donafenib combined with tislelizumab.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Donafenib + Tislelizumab	Donafenib 100mg, BID+Tislelizumab 200mg, D1; q3w

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-11-01
• Completion: 2024-11-01
• First posted: 2022-09-19
• Last updated: 2022-09-19