OncoMatch/Clinical Trials/NCT07062263
Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients
Is NCT07062263 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Trastuzumab and Chemotherapy for biliary tract cancer.
Treatment: Trastuzumab · Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) positive by IHC or FISH
HER2-positive by IHC or FISH
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: adjuvant chemotherapy completed more than 12 months before study enrollment is allowed
Received prior chemotherapy within 1 year. Subjects who have received adjuvant chemotherapy will be considered eligible provided that therapy is completed more than 12 months before study enrollment. Patients with prior chemotherapy for metastatic disease will be ineligible for enrollment in the study.
Lab requirements
Blood counts
Hb > 80 g/L, ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L
Kidney function
Creatinine ≤ 1.5 ULN, Creatinine clearance ≥ 30 mL/min
Liver function
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
Cardiac function
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.
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. 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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