MedTrace Logo

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

NCT07598318 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2027-12-31
Completion
2028-12-31

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07598318 on ClinicalTrials.gov