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OncoMatch/Clinical Trials/NCT06859684

Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)

Is NCT06859684 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and hepatic arterial infusion chemotherapy (HAIC) for intrahepatic cholangiocarcinoma (icc).

Phase 2RecruitingWest China HospitalNCT06859684Data as of May 2026

Treatment: Durvalumab · hepatic arterial infusion chemotherapy (HAIC) · LenvatinibAt present, the first-line treatment for patients with advanced unresectable intrahepatic cholangiocarcinoma is mainly systemic treatment, but the improvement in efficacy is limited and is not enough to meet the current clinical treatment needs. Hepatic artery infusion chemotherapy (HAIC) has the advantages of increasing local drug concentration and reducing toxic side effects compared to systemic intravenous chemotherapy. In order to enable patients with advanced intrahepatic cholangiocarcinoma to obtain better treatment effects, this study plans to explore HAIC combined with durvalumab and lenvatinib as the first-line treatment for patients with locally advanced or metastatic ICC, in order to provide a better treatment choice for their comprehensive treatment.

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Performance status

WHO/ECOG 0–1

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic treatment

Exception: Disease recurrence > 6 months after radical surgery; if adjuvant therapy is given after surgery, patients > 6 months after completion of adjuvant therapy (chemotherapy and/or radiotherapy) are eligible

Patients who have received systemic treatment in the past

Lab requirements

Blood counts

Excludes severe and uncorrectable coagulation dysfunction

Liver function

Excludes severe liver dysfunction (Child-Pugh C grade), significant jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome

Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome. Patients with severe and uncorrectable coagulation dysfunction.

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

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