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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 (Jun 2026). This Phase 2 trial studies multiple treatments for cholangiocarcinoma.

Phase 2RecruitingNational Cancer Institute, NaplesNCT06341764Data as of Jun 2026Location: Italy

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

Treatments studied

Immunotherapy

Durvalumab 1120 mgDurvalumab 1500 mg

Chemotherapy

Cisplatin (CDDP) 25 mg/mq i.vGemcitabine (GEM) 1000 mg/mq i.v.

Other

Tremelimumab i.v. at 300 mg

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.

Frequently asked questions

Is NCT06341764 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.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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