NCT07472933

Vebotolimab Combined With Ptorlimab for EGFR-positive Refractory Advanced Biliary Tract Malignancies

An Exploratory Study of Vedotin-tislelizumab Combined With Toripalimab in EGFR-positive Refractory Advanced Biliary Tract Malignancies

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to observe the efficacy and safety of the combination of vebecotototo monoclonal antibody and putli monoclonal antibody in the treatment of EGFR-positive refractory biliary malignant tumors.

Conditions

• Cancer of Biliary Duct

Interventions

Type	Name	Description
DRUG	Vibecotecotamab combined with Putilimab for EGFR-positive refractory biliary malignant tumors	This study is a single-arm, prospective, phase II clinical trial, aiming to enroll patients with advanced biliary system tumors who have failed at least one line of standard treatment and are positive for EGFR. After the subjects sign the informed consent, those who are confirmed to meet the inclusion criteria undergo treatment with puzelimab, 200mg per dose, intravenous infusion on D1, once every 3 weeks; vibercept, 2.0mg/kg, intravenous infusion on D1, once every 3 weeks. The combination therapy will continue until disease progression or intolerable side effects occur.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-02-29
• Completion: 2028-02-29
• First posted: 2026-03-16
• Last updated: 2026-03-18

Locations

1 site across 1 country: China