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)

Sichuan University

Status and phase: Enrolling; Phase 2

Conditions: Durvalumab; Intrahepatic Cholangiocarcinoma (Icc); HAIC

Treatments: Drug: Lenvatinib; Drug: Durvalumab; Drug: hepatic arterial infusion chemotherapy (HAIC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06859684

HAIC-quad-01

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

HAIC-quad Arm

Experimental group

Treatment:

Drug: hepatic arterial infusion chemotherapy (HAIC)

Drug: Durvalumab

Drug: Lenvatinib