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Completed

NCT Number: NCT07304388

HAIC Plus Systemic Chemotherapy, Lenvatinib and Toripalimab in Advanced ICC

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.

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Key information

Conditions

Intrahepatic Cholangiocarcinoma (Icc) Adenocarcinoma Carcinoma Cholangiocarcinoma Cirrhosis, Familial, with Pulmonary Hypertension Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. 6-months PFS

    Time frame: 6 months

    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.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 18 months

    ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.

  2. Overall Survival (OS)

    Time frame: 18 months

    OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

  3. Progression Free Survival (PFS)

    Time frame: 18 months

    PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.

  4. Adverse Events

    Time frame: 30 days

    Number of adverse events. Postoperative adverse events were graded based on CTCAE v5.0

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Systemic Chemotherapy, Lenvatinib and Toripalimab With or Without Hepatic Arterial Infusion In Advanced Intrahepatic Cholangiocarcinoma: A Prospective, Randomized, Two-Cohort, Phase II Study.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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