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NOT YET RECRUITING
NCT07598318
PHASE2/PHASE3

Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations

Sponsor: Sir Run Run Shaw Hospital

View on ClinicalTrials.gov

Summary

This study tests whether adding becotatug vedotin (EGFR-ADC) to standard chemotherapy plus immunotherapy improves outcomes compared to chemotherapy plus immunotherapy alone as first-line treatment for patients with advanced or metastatic biliary tract cancer whose tumors carry EGFR mutations. Participants will be randomly assigned to receive either the experimental combination (becotatug vedotin + pucotenlimab + gemcitabine + cisplatin) or the control combination (pucotenlimab + gemcitabine + cisplatin). The main goal is to see if the experimental group has a higher objective response rate (tumor shrinkage rate). This is a randomized, controlled, open-label, multicenter study led by Sir Run Run Shaw Hospital, Zhejiang University, with Dr. Chen Mingyu as the principal investigator.

Official title: A Randomized, Controlled, Open-Label, Multi-center Study of Becotatug Vedotin (EGFR-ADC) Combined With Chemo and Immunotherapy vs. Chemo and Immunotherapy as First-Line Treatment in Advanced/Metastatic EGFR-Mutated Biliary Tract Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

164

Start Date

2026-05-20

Completion Date

2028-12-31

Last Updated

2026-05-20

Healthy Volunteers

No

Interventions

DRUG

Becotatug Vedotin

Becotatug Vedotin:2mg/kg,IV,Q3W,D1

DRUG

Pucotenlimab

Pucotenlimab:200mg,IV,Q3W,D1

DRUG

Gemcitabine

Gemcitabine:1000mg/m²,IV,D1、D8,Q3W. Each course lasts for 8 weeks. The maximum treatment duration is 8 courses.

DRUG

Cisplatin

Cisplatin:25mg/m²,IV,D1、D8,Q3W. Each course lasts for 8 weeks. The maximum treatment duration is 8 courses.