NCT06413017

Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure

Nimotuzumab Combined With Immune Checkpoint Inhibitors for the Treatment of Advanced Liver Cancer After First Line Treatment Failure ，a Prospective， Open Label，Single Arm，Phase II Trail

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 17 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy

Detailed description

This study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protoPD-1 (or PD-L1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, D1, QW in combination with PD-1 (or PD-L1) inhibitor in the later line of treatment until disease progression and intolerable toxicity

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	Nimotuzumab	Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity
DRUG	ICIs(Immune checkpoint inhibitors)	Use it as it is describe in the instructions from the specification

Timeline

• Start date: 2023-08-31
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2024-05-14
• Last updated: 2024-05-14

Locations

1 site across 1 country: China