OncoMatch/Clinical Trials/NCT07670273
Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive/HER2-Low Biliary Tract Cancer
Official title: A Prospective, Open-label, Multicenter Phase II Clinical Study of Rikang Trastuzumab in Combination With Adebrelimab and Lenvatinib for First-line Treatment of HER2-positive or Low-expressing Locally Advanced or Metastatic Biliary Tract Cancer
Is NCT07670273 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Trastuzumab Rezetecan and Adebrelimab for biliary tract neoplasms immunotherapy.
Treatment: Trastuzumab Rezetecan · Adebrelimab · Lenvatinib — This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.
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 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
Cannot have received: immunotherapy
Cannot have received: her2-targeted therapy
Cannot have received: antibody-drug conjugate
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% excluded; corrected QT interval (QTe) > 480ms excluded
The organs and bone marrow have sufficient functions and meet the following requirements: ... Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 75 × 10^9/L; ... Serum total bilirubin ≤ 2xULN (for Gilbert syndrome patients, ≤ 3xULN); ALT and AST ≤ 3.0xULN; for patients with liver metastasis, ALT and AST ≤ 5xULN; Serum creatinine ≤ 1.5xULN or endogenous creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula); LVEF < 50% excluded; corrected QT interval (QTe) > 480ms excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07670273 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
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 75 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