Condition: Biliary Tract Cancer · HER2-positive Cancer · Advanced Cancer · Sponsor: Tata Memorial Centre
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 aim…
This description comes directly from the study's public registry record.
Vikas S Ostwal, DM · 0222417000 · dr.vikas.ostwal@gmail.com
Anant Ramaswamy, DM · 0222417000 · anantr13@gmail.com
Always discuss trial participation with your own doctor first.
| Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur | Muzaffarpur, Bihar, India | Not Yet Recruiting |
| Tata Memorial Hospital | Mumbai, Maharashtra, India | Recruiting |
| Institute of Medical Sciences & SUM Hospital | Bhubaneswar, Odisha, India | Not Yet 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 |
| MAX Super Speciality Hospital, SAKET | Delhi, India | Not Yet Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07062263