Combining HAIC with Durvalumab and Lenvatinib for Advanced Intrahepatic Cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of hepatic arterial infusion chemotherapy (HAIC) combined with durvalumab and lenvatinib as a first-line treatment for patients with locally advanced or metastatic intrahepatic cholangiocarcinoma. The approach aims to enhance local drug concentration while minimizing systemic side effects compared to traditional chemotherapy. By targeting patients with unresectable or metastatic disease, the study seeks to provide a more effective treatment option for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminary diagnosis of unresectable or metastatic disease and no previous systemic treatment.

   Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein or main bile duct, who cannot undergo resection and reconstruction; ② Patients with decompensated cirrhosis or severe portal hypertension, and the residual liver FLR does not meet the safe liver resection decision-making system Biological factors: ① Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodes such as the para-aorta or distant organ metastasis
2. 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 for inclusion.
3. WHO/ECOG PS of 0 or 1
4. There was at least 1 target lesion (TL) that met the RECIST 1.1 criteria

Exclusion Criteria:

1. Patients who have received systemic treatment in the past.
2. Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
3. Patients with severe and uncorrectable coagulation dysfunction.
4. Patients with active hepatitis or severe infection who cannot be treated simultaneously.
5. Patients with cachexia or multiple organ failure.

Where it's running

• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Yun X Zhang, PHD
• Email: zhangxiaoyun@wchscu.cn
• Phone: 18011410585

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.