Actively Recruiting
Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients
Led by Tata Memorial Centre · Updated on 2025-07-14
220
Participants Needed
6
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the biliary tract, including gallbladder cancer, intrahepatic cholangiocarcinoma, or perihilar cholangiocarcinoma.
- HER2-positive status confirmed by IHC or FISH.
- Age 18 years or older.
- ECOG performance status between 0 and 2.
- Unresectable or metastatic biliary tract cancer.
- No contraindications to chemotherapy or trastuzumab.
- Adequate blood counts: Hemoglobin > 80 g/L, ANC 65 1.5 x 10^9/L, platelets 65 100 x 10^9/L.
- Adequate liver function: bilirubin 64 2 times upper limit normal (ULN), AST/ALT 64 5 times ULN, alkaline phosphatase 64 6 times ULN, serum albumin 65 30 g/L.
- Adequate kidney function: creatinine 64 1.5 ULN, creatinine clearance 20 mL/min.
- Normal cardiac function with ejection fraction 65 50% or above lower limit of normal; ECG without major abnormalities.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during treatment.
- Written informed consent and willingness to comply with study procedures.
- Completed adjuvant chemotherapy more than 12 months prior to enrollment, and completed radiation and surgery at least 3 and 2 weeks before enrollment, respectively.
- Negative serum pregnancy test if applicable and agreement to contraception.
- At least one measurable tumor lesion per RECIST criteria.
- Life expectancy of at least 12 weeks.
You will not qualify if you...
- Diagnosis of distal cholangiocarcinoma.
- Known allergies or contraindications to gemcitabine, cisplatin, nab-paclitaxel, or trastuzumab.
- Active or significant coronary heart disease, cardiomyopathy, or congestive heart failure classified as NYHA III-IV.
- Significant heart valve defects.
- History of other cancers not cured or disease-free for less than 5 years, except for certain skin and cervical cancers.
- Severe shortness of breath at rest due to advanced cancer or requiring oxygen therapy.
- Peripheral neuropathy greater than NCI Grade I.
- Pregnant, breastfeeding, or planning pregnancy within 6 months after treatment.
- Received chemotherapy within the past year.
- Active interstitial lung disease or history of lung illness requiring bronchodilators.
- Prior chemotherapy for metastatic disease is not allowed.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur
Muzaffarpur, Bihar, India, 842004
Not Yet Recruiting
2
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
3
Institute of Medical Sciences & SUM Hospital
Bhubaneswar, Odisha, India, 751003
Not Yet Recruiting
4
Homi Bhabha Cancer Hospital and Research Centre
Mūllānpur, Punjab, India, 140901
Actively Recruiting
5
Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMC) and Homi Bhabha Cancer Hospital (HBCH)
Varanasi, Uttar Pradesh, India, 221005
Actively Recruiting
6
MAX Super Speciality Hospital, SAKET
Delhi, India, 110017
Not Yet Recruiting
Research Team
V
Vikas S Ostwal, DM
CONTACT
A
Anant Ramaswamy, DM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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