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OncoMatch/Clinical Trials/NCT06341764

Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma

Is NCT06341764 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for cholangiocarcinoma.

Phase 2RecruitingNational Cancer Institute, NaplesNCT06341764Data as of May 2026

Treatment: Durvalumab 1120 mg · Durvalumab 1500 mg · Tremelimumab i.v. at 300 mg · Cisplatin (CDDP) 25 mg/mq i.v · Gemcitabine (GEM) 1000 mg/mq i.v.Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.

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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: systemic therapy

No previous systemic or local treatments including radiation therapy, radiofrequency ablations, electro-chemotherapy.

Cannot have received: local therapy

No previous systemic or local treatments including radiation therapy, radiofrequency ablations, electro-chemotherapy.

Cannot have received: radiation therapy

No previous systemic or local treatments including radiation therapy, radiofrequency ablations, electro-chemotherapy.

Cannot have received: radiofrequency ablation

No previous systemic or local treatments including radiation therapy, radiofrequency ablations, electro-chemotherapy.

Cannot have received: electro-chemotherapy

No previous systemic or local treatments including radiation therapy, radiofrequency ablations, electro-chemotherapy.

Lab requirements

Blood counts

Haemoglobin ≥9.0 g/dL; ANC ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L

Kidney function

Measured or calculated creatinine clearance >40 mL/min

Liver function

Serum bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome); AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case ≤5x ULN

Adequate normal organ and marrow function as defined below: Haemoglobin ≥9.0 g/dL; ANC ≥1.5 × 10^9 /L; Platelet count ≥100 × 10^9/L; Serum bilirubin ≤1.5 x institutional ULN (except Gilbert's syndrome); AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case ≤5x ULN; Measured or calculated creatinine clearance >40 mL/min

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

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