OncoMatch/Clinical Trials/NCT07704177
Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive/Low-Expression Biliary Tract Cancer
Is NCT07704177 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Trastuzumab Rezetecan and Adebrelimab for biliary tract neoplasms immunotherapy.
Treatment: Trastuzumab Rezetecan · Adebrelimab · Lenvatinib — An investigation into the survival outcomes, progression-free survival, and safety of triple therapy with Trastuzumab Rezetecan, Adebrelimab, and Lenvatinib in patients with advanced HER2-positive/low-expressing biliary tract cancer after the failure of at least two prior systemic therapies.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ and FISH detects HER2/CEP17 ≥ 2.0)
HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2/CEP17 ≥ 2.0)
Required: HER2 (ERBB2) expression (IHC 2+/FISH- or IHC 1+)
HER2 low expression (IHC 2+/FISH- or IHC 1+)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic therapy
Having progressed or experienced intolerance after at least one systemic treatment regimen in the past
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; Neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 75 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5xULN or endogenous creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula)
Liver function
Serum total bilirubin ≤ 2xULN (for Gilbert syndrome patients, ≤ 3xULN); ALT and AST ≤ 3.0xULN; for patients with liver metastasis, ALT and AST ≤ 5xULN
Cardiac function
LVEF < 50%; corrected QT interval (QTe) > 480ms; poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg, based on the average value obtained from ≥ 2 measurements); previous occurrence of hypertensive crisis or hypertensive encephalopathy
The organs and bone marrow have sufficient functions and meet the following requirements: ... Blood routine examination ... Blood biochemical examination ... cardiac echocardiography showed left ventricular ejection fraction (LVEF) < 50%; corrected QT interval (QTe) > 480ms ... poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg ... previous occurrence of hypertensive crisis or hypertensive encephalopathy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07704177 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages