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

RecruitingPhase 3Ages 18 Years - 99 YearsAllTata Memorial Centre
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: Histologically confirmed adenocarcinoma of the biliary tract, with the following specifications - 1. Biliary tract cancers include gallbladder cancer, intrahepatic cholangiocarcinoma, and perihilar cholangiocarcinoma. 2. HER2-positive by IHC or FISH 3. Age \>=18 years. 4. ECOG performance status 0 - 2. 5. Unresectable or metastatic cancer. 6. Patient does not have any contraindications to receive chemotherapy or trastuzumab. 7. Adequate hematological, hepatic, and renal function parameters- Hematological- Hb\> 80 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L. Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST/ALT ≤ 5 x ULN, alkaline phosphatase ≤ 6 x upper limit normal (ULN) S. albumin ≥ 30 g/L. Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \>= 30 mL/min. 8. Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction (EF) \>=50% or above the lower limit of normal. ECG with no clinically relevant abnormalities. 9. Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial. 10. Subjects must provide written informed consent prior to the performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up assessments and procedures. 11. Subjects who have received adjuvant chemotherapy will be considered eligible provided that therapy is completed more than 12 months before study enrollment. Patients who have received radiation therapy and surgery will also be eligible provided the interventions have been completed 3 and 2 weeks, respectively, before enrolment in the study. 12. Negative serum pregnancy test (if applicable) and willing for adequate contraception. 13. At least one measurable disease according to RECIST criteria. 14. Life expectancy of at least 12 weeks. Exclusion Criteria: 1. Distal cholangiocarcinoma 2. Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab- paclitaxel, or trastuzumab. 3. Clinically significant active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA III-IV. 4. Clinically significant valvular defect. 5. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix. 6. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. 7. Baseline neuropathy \> NCI Grade I. 8. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment. 9. Received prior chemotherapy within 1 year. 10. Any active ILD/ history of lung illness requiring bronchodilator drugs. 11. Patients with prior chemotherapy for metastatic disease will be ineligible for enrollment in the study.
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What it tests

  • Trastuzumab
  • Chemotherapy
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Where

6 sites
Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur
Muzaffarpur, India
Tata Memorial Hospital
Mumbai, India
Institute of Medical Sciences & SUM Hospital
Bhubaneswar, India
Homi Bhabha Cancer Hospital and Research Centre
Mūllānpur, India
Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMC) and Homi Bhabha Cancer Hospital (HBCH)
Varanasi, India
MAX Super Speciality Hospital, SAKET
Delhi, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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