Actively Recruiting
Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients - a Randomized Non-blinded Two-arm Phase III Prospective Clinical Trial (TAB-2 Study)
Led by Tata Memorial Centre · Updated on 2025-07-14
220
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of adding trastuzumab to chemotherapy compared to chemotherapy alone as a first treatment in patients with HER2-positive advanced or metastatic biliary tract cancers. These cancers, including gallbladder cancer and cholangiocarcinomas, are rare and aggressive with limited treatment options and poor prognosis. This Phase III trial builds on earlier findings suggesting potential benefit from trastuzumab in this molecular subgroup. Participants will be randomly assigned to one of two groups. One group will receive trastuzumab combined with chemotherapy regimens including gemcitabine and cisplatin, with or without nab-paclitaxel. The other group will receive chemotherapy alone, using similar drugs but without trastuzumab. Treatments are given in cycles every three weeks and continue until the disease worsens, unacceptable side effects occur, consent is withdrawn, or death. Immunotherapy may also be given based on physician choice. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor their cancer and overall health. Researchers will measure progression-free survival at six months as the main outcome, along with overall survival, response rates, quality of life, and safety throughout treatment cycles. The study plans to enroll 196 patients over five years with an additional six months of follow-up after the last patient is enrolled.
CONDITIONS
Brief 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 by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
- Age 18 years or older
- ECOG performance status of 0 to 2
- Unresectable or metastatic biliary tract cancer
- No contraindications to receive chemotherapy or trastuzumab
- Adequate blood counts: hemoglobin > 80 g/L, absolute neutrophil count ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L
- Adequate liver function: bilirubin ≤ 2 times upper limit normal (ULN), AST/ALT ≤ 5 times ULN, alkaline phosphatase ≤ 6 times ULN, serum albumin ≥ 30 g/L
- Adequate kidney function: creatinine ≤ 1.5 ULN, creatinine clearance ≥ 30 mL/min
- Normal heart function with ejection fraction ≥ 50% and no significant ECG abnormalities
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during treatment
- Written informed consent provided and willingness to comply with study procedures
- Completed any prior adjuvant chemotherapy more than 12 months before enrollment
- Completed radiation therapy and surgery at least 3 and 2 weeks before enrollment, respectively
- At least one measurable tumor lesion according to RECIST criteria
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Distal cholangiocarcinoma
- Known allergy or contraindication to gemcitabine, cisplatin, nab-paclitaxel, or trastuzumab
- Active severe heart disease including coronary heart disease, cardiomyopathy, or congestive heart failure NYHA class III-IV
- Significant heart valve defects
- History of other cancers not cured or disease-free for less than 5 years, except treated basal cell skin cancer or cervical carcinoma in situ
- Severe breathlessness at rest or requiring oxygen therapy due to advanced cancer complications
- Peripheral neuropathy greater than National Cancer Institute Grade I
- Pregnant or breastfeeding, or planning pregnancy within 6 months after treatment
- Received chemotherapy within the last year
- Active interstitial lung disease or lung illness needing bronchodilators
- Prior chemotherapy for metastatic disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing cycles of 3 weeks each until disease progression or withdrawal
Participants receive chemotherapy with or without trastuzumab every 3 weeks. Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent.
Visits on Day 1 and Day 8 of each 3-week cycle
Duration - Up to 6 months post-treatment
Participants are monitored for progression-free survival and overall survival for up to 6 months after treatment completion.
Visits scheduled as per study follow-up protocols
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
A
Anant Ramaswamy, DM
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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