OncoMatch/Clinical Trials/NCT07291947

PULSAR Combined With Immunotherapy and Chemotherapy

Is NCT07291947 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Iparomlimab and Tuvonralimab for cholangiocarcinoma.

Phase 1/2RecruitingWang XinNCT07291947Data as of May 2026

Treatment: Iparomlimab and Tuvonralimab — The primary objective of this study is to evaluate the efficacy and safety of PULSAR in combination with dual immune checkpoint inhibitors (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) and GC chemotherapy in patients with locally advanced or metastatic cholangiocarcinoma. The secondary objective of this study is to investigate the immunological impact of PULSAR combined with dual immune therapy (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) on the tumor microenvironment and systemic immune responses in cholangiocarcinoma patients.

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: anti-PD-1 therapy

Previously treated with anti-PD-1 antibodies

Cannot have received: anti-PD-L1 therapy

Previously treated with anti-PD-L1 antibodies

Cannot have received: systemic therapy

Previously received systemic therapy for cholangiocarcinoma

Cannot have received: investigational drug

Received any investigational drug treatment within 4 weeks prior to the first administration of the study drug

Cannot have received: radiotherapy

Previously received radiotherapy to the upper abdomen

Lab requirements

Blood counts

ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 80 × 10⁹/L; Hemoglobin ≥ 90 g/L

Kidney function

Serum creatinine ≤ 1.5x ULN or creatinine clearance rate ≥ 50 ml/min

Liver function

Total bilirubin ≤ 1.5x ULN; AST and ALT ≤ 2.5x ULN (≤ 5x ULN if liver metastases present)

Organ function levels meet the following requirements: - Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; - Platelet (PLT) count ≥ 80 × 10⁹/L; - Hemoglobin (Hb) level ≥ 90 g/L; - Total bilirubin (TBil) level ≤ 1.5 times the upper limit of normal (ULN); - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; if liver metastases are present, ≤ 5 times ULN; - Serum creatinine ≤ 1.5 times ULN, or calculated creatinine clearance rate ≥ 50 ml/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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