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HAIC Plus Systemic Chemotherapy, Lenvatinib and Toripalimab in Advanced ICC

NCT ID: NCT07304388

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Intrahepatic Cholangiocarcinoma (Icc)

Keywords

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lenvatinib HAIC GemOx combined therapy immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Group Type EXPERIMENTAL

hepatic arterial infusion chemotherapy (HAIC)

Intervention Type 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

Control arm: Gemox plus lenvatinib and toripalimab

Group Type ACTIVE_COMPARATOR

Chemotherapy

Intervention Type 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

Interventions

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hepatic arterial infusion chemotherapy (HAIC)

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

Intervention Type PROCEDURE

Chemotherapy

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Shi Ming

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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IA3GM-II

Identifier Type: -

Identifier Source: org_study_id