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Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients

NCT07062263 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-07-14

No results posted yet for this study

Summary

This is a randomized, open-label, two-arm, Phase III clinical trial evaluating the efficacy and safety of trastuzumab plus chemotherapy versus chemotherapy alone as first-line treatment in patients with HER2-positive advanced or metastatic biliary tract cancers (BTC). HER2-positive BTCs represent a molecular subset of these rare cancers, associated with poor prognosis and limited treatment options.

Eligible patients with histologically confirmed HER2-positive (IHC 3+ or IHC 2+ with FISH amplification) unresectable or metastatic biliary tract adenocarcinoma-including gallbladder cancer, intrahepatic, and perihilar cholangiocarcinoma-will be randomized in a 1:1 ratio. Participants in the intervention arm (Arm A) will receive either gemcitabine and cisplatin with or without nab-paclitaxel plus trastuzumab, while those in the control arm (Arm B) will receive chemotherapy alone (gemcitabine + cisplatin with or without nab-paclitaxel). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or death.

The primary endpoint is 6-month progression-free survival (PFS). Secondary endpoints include overall survival (OS), response rate (RR), quality of life (QOL), and adverse event (AE) profiles. The study aims to enroll 196 patients across a single center in India over a period of 5 years, with an additional 6-month follow-up. This trial builds on earlier Phase II findings suggesting improved outcomes with trastuzumab in HER2-positive BTC and aims to provide the first randomized evidence for the benefit of HER2-targeted therapy in this setting.

Conditions

  • Biliary Tract Cancer
  • HER2-positive Cancer
  • Advanced Cancer
  • Unresectable Biliary Tract Carcinoma
  • Metastatic Biliary Tract Carcinoma

Interventions

DRUG

Trastuzumab

Inj Trastuzumab given in a dose of 8mg/kg intravenously over 90 mins as first dose and subsequent doses at a dose of 6mg/kg intravenously over 30-60 minutes in 3 weekly cycle along with standard of care chemotherapy

DRUG

Chemotherapy

Gemcitabine + cisplatin OR Gemcitabine-cisplatin-Nab-Paclitaxel given as a standard of care, chemotherapy as per the institutional guidlines

Sponsors & Collaborators

  • Tata Memorial Centre

    lead OTHER

Principal Investigators

  • Vikas Ostwal, DM · Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India 400012

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • India

Study Locations

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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 NCT07062263 on ClinicalTrials.gov