Trastuzumab plus chemotherapy versus chemotherapy alone for first-line HER2-positive advanced biliary tract cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label Phase III trial that enrolls adults with unresectable or metastatic HER2-positive biliary tract adenocarcinoma and randomizes them 1:1 to receive gemcitabine/cisplatin (with or without nab-paclitaxel) either with or without trastuzumab. HER2 positivity is defined as IHC 3+ or IHC 2+ with FISH amplification. Treatment continues until disease progression or unacceptable toxicity, with regular clinical and imaging assessments to measure response and safety. The trial is being conducted at multiple tertiary cancer centers in India.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tata Memorial Hospital
  Mumbai, Maharashtra, India Recruiting
• Homi Bhabha Cancer Hospital and Research Centre
  Mūllānpur, Punjab, India Recruiting
• Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMC) and Homi Bhabha Cancer Hospital (HBCH)
  Varanasi, Uttar Pradesh, India Recruiting
• Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur
  Muzaffarpur, Bihar, India Not yet recruiting
• Institute of Medical Sciences & SUM Hospital
  Bhubaneswar, Odisha, India Not yet recruiting
• MAX Super Speciality Hospital, SAKET
  Delhi, India Not yet recruiting

Study contacts

• Principal investigator: Vikas Ostwal, DM — Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India 400012
• Study coordinator: Vikas S Ostwal, DM
• Email: dr.vikas.ostwal@gmail.com
• Phone: 0222417000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.