HAIC Plus Systemic Chemotherapy, Lenvatinib and Toripalimab in Advanced ICC

NCT07304388 | Completed Phase 2 DMC

• 1 other identifier: IA3GM-II
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Prognosis for unresectable intrahepatic cholangiocarcinoma (ICC) remains poor. Treatment combination known as Gemox (systemic chemotherapy of gemcitabine and oxaliplatin), along with lenvatinib and toripalimab, has shown favor results for ICC patients. However, Hepatic Arterial Infusion Chemotherapy (HAIC), which delivers chemotherapy directly to the liver, has also demonstrated benefits in controlling the cancer locally and improving survival for patients with ICC. Based on these promising approaches, this study aims to find out if adding HAIC to the systemic chemotherapy-based treatment can help extending patients survival.

Conditions

Intrahepatic Cholangiocarcinoma (Icc)

Keywords

HAIC; GemOx; combined therapy; lenvatinib; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 6-months PFS

  6-months Progression-Free Survival Rate (6-months PFS rate) is defined as the proportion of patients who remain alive and free from disease progression (as assessed by RECIST v1.1) at 6 months from the initiation of study randomization.

  6 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  18 months

• Overall Survival (OS)

  18 months

• Progression Free Survival (PFS)

  18 months

• Adverse Events

  30 days

Study Arms (2)

Experimental arm: Hepatic arterial infusion plus systemic chemotherapy, lenvatinib and toripalimab

EXPERIMENTAL

Procedure: hepatic arterial infusion chemotherapy (HAIC)

Control arm: Gemox plus lenvatinib and toripalimab

ACTIVE COMPARATOR

Drug: Chemotherapy

Interventions

hepatic arterial infusion chemotherapy (HAIC) PROCEDURE

Hepatic arterial infusion chemotherapy: oxaliplatin 85mg/m2 via HAIC pump for 3 hours on day 1; Q3W Drug: Gemcitabine 1g/m2 intravenously on day 1 and day 8 of a 3 weeks cycle Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing Drug: Toripalimab 240 mg iv.drip Q3W

Experimental arm: Hepatic arterial infusion plus systemic chemotherapy, lenvatinib and toripalimab

Chemotherapy DRUG

Systemic chemotherapy of GemOx regimen: oxaliplatin 85mg/m2 and gemcitabine 1g/m2 intravenously on day 1, and gemcitabine 1g/m2 intravenously on day 8 of a 3 weeks cycle. Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing Drug: Toripalimab 240 mg iv.drip Q3W

Control arm: Gemox plus lenvatinib and toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven ICC with locally advanced or metastatic disease deemed unresectable by multidisciplinary evaluation; At least one measurable disease according to the Response Evaluation Criteria in Solid Tumors（RECIST v1.1）; Child-Pugh class A or B; ECOG performance status 0-1; Adequate bone marrow function（white blood cell count ≥2,000cells/mm3, hemoglobin \> 9.0 g/dL, Platelet count ≥75,000/mm3）; Adequate hepatic and renal function (albumin ≥ 30 g/L, total bilirubin \< 3 times the upper limit of normal, aspartate and alanine transaminases \< 5 times the upper limit of normal, creatinine clearance rate of ≤ 1.5 times the upper limit of the normal) and coagulation function（PT \< 18s, INR \< 1.26）; written informed consent.

You may not qualify if:

• Life expectancy less than 2 months; concurrent other malignancy; Prior anticancer therapy (including chemotherapy, radiotherapy, surgery, or interventional treatments); Known allergy to chemotherapy drugs, lenvatinib or PD-(L)1 inhibitors; Patients with uncontrolled comorbidities, active infections; pregnancy or lactation; Refuse to comply with study and/or follow-up procedures; Gastrointestinal bleeding of any grade within 4 weeks prior to the treatment.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 26, 2025
• Study Start: February 10, 2023
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CN (1)