RecruitingPhase 2NCT06859684

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)


Sponsor

West China Hospital

Enrollment

25 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

At 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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing a combination of hepatic arterial infusion chemotherapy (HAIC — chemo delivered directly into the liver's blood supply), durvalumab (an immunotherapy drug), and lenvatinib (a targeted drug) for patients with advanced bile duct cancer (intrahepatic cholangiocarcinoma) who have not yet received systemic treatment. **You may be eligible if...** - You have a confirmed diagnosis of intrahepatic cholangiocarcinoma (bile duct cancer inside the liver) - Your cancer is unresectable (cannot be surgically removed) or has spread to other organs - You have not received prior systemic (whole-body) cancer treatment **You may NOT be eligible if...** - You have severe liver dysfunction (Child-Pugh C), significant jaundice, hepatic encephalopathy, refractory fluid buildup (ascites), or hepatorenal syndrome - You have a severe blood clotting disorder - You have active hepatitis or serious infection that cannot be treated alongside the study treatment - You have severe malnutrition or multiple organ failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W

DRUGhepatic arterial infusion chemotherapy (HAIC)

hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was adopted, with the specific regimen as follows: cisplatin 60 mg/m2 on the first day, arterial infusion for half an hour, gemcitabine 1000 mg/m2 on the first day, arterial infusion for half an hour, repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles was determined by the investigator according to the patient's condition).

DRUGLenvatinib

Lenvatinib 8mg (weight \<60 kg) or 12mg (weight ≥60 kg) oral QD, during combination therapy, starting on day 3 of each 3-week cycle (determined by the investigator)


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT06859684


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