• TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma

  NCT04954781

  RecruitingInterventionalPhase 2Updated Feb 27, 2025
• Combined Therapy Using D-TACE, Gemcitabine and Cisplatin, and PD1 Antibody in Advanced and Unresectable Intrahepatic Cholangiocarcinoma

  NCT05738057

  Unknown statusInterventionalPhase 2Updated Nov 29, 2023
• TACE Combined With "Target Immune" Therapy for First-line Treatment in the Treatment of Intrahepatic Cholangiocarcinoma

  NCT05247996

  Unknown statusInterventionalNot ApplicableUpdated Feb 21, 2022
• Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study

  NCT05342194

  RecruitingInterventionalPhase 3Updated Apr 23, 2025
• TACE Combined With Tyrosine Kinase Inhibitors and Tislelizumab in Unresectable Hepatocellular Carcinoma

  NCT06232759

  CompletedInterventionalPhase 2Updated Jun 10, 2024
• HAIC + DEB-TACE + Toripalimab + Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma

  NCT07685535

  Not yet recruitingInterventionalPhase 2Updated Jul 6, 2026

ClinicalTrials.gov ID

NCT07691515

Lead Sponsor

Zhejiang Cancer HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

140Estimated

Last Update Posted

Jul 14, 2026Actual

Start Date

Jul 2026Estimated

Primary Completion Date

Jan 2030Estimated

Completion Date

Jul 2030Estimated

Official Title

Transcatheter Arterial Chemoembolization in Combination With Tislelizumab Plus Lenvatinib Versus Systemic Cisplatin Plus Gemcitabine in Combination With Tislelizumab for Unresectable Intrahepatic Cholangiocarcinoma: A Phase III, Multicenter, Randomized Controlled Trial

Brief Summary

This is a phase III, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of arterially directed therapy in combination with tislelizumab plus lenvatinib compared with gemcitabine and cisplatin (GEMCIS) in combination with tislelizumab as first-line treatment for patients with unresectable intrahepatic cholangiocarcinoma.

Approximately 140 eligible patients with histologically confirmed unresectable intrahepatic cholangiocarcinoma without extrahepatic metastasis will be enrolled and randomized in a 1:1 ratio to receive either TACE plus tislelizumab and lenvatinib or GEMCIS plus tislelizumab. In the TACE-based treatment arm, hepatic arterial infusion chemotherapy with gemcitabine and cisplatin may be administered during or after TACE at the investigator's discretion according to the protocol.

The primary endpoint is overall survival. Secondary endpoints include progression-free survival, time to progression, objective response rate, disease control rate, safety, and quality of life.

• Intrahepatic Cholangiocarcinoma (Icc)

• Gemcitabine
• Cisplatin
• Tislelizumab
• Lenvatinib
• Transcatheter Arterial Chemoembolization
• Hepatic Arterial Infusion Chemotherapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Age ≥18 years.

2. Histologically confirmed intrahepatic cholangiocarcinoma that is unresectable or recurrent after curative treatment, without extrahepatic metastasis.

3. No prior systemic therapy or transarterial interventional therapy for intrahepatic cholangiocarcinoma.

4. At least one measurable intrahepatic lesion according to RECIST v1.1.

5. ECOG performance status of 0 or 1.

6. Child-Pugh class A liver function.

7. Life expectancy ≥3 months.

8. Adequate hematologic, hepatic, renal, and thyroid function within 14 days before study start, defined as:

   • Absolute neutrophil count ≥1.5 × 10⁹/L;
   • Platelet count ≥75 × 10⁹/L;
   • Hemoglobin ≥90 g/L;
   • Serum albumin ≥30 g/L;
   • Total bilirubin ≤1.5 × upper limit of normal;
   • AST and ALT <1.5 × upper limit of normal, and ALP <4 × upper limit of normal;
   • TSH <1 × upper limit of normal, with T3 and T4 within the normal range;
   • Serum creatinine <1.5 × upper limit of normal and creatinine clearance ≥60 mL/min.

Exclusion Criteria:

1. Diffuse infiltrative liver lesions.
2. Contraindications to TACE.
3. Allergy to intravenous contrast agent.
4. pregnant or breastfeeding women, or participants planning pregnancy within 2 years / unwilling to use effective contraception.
5. Patients with HIV or syphilis infection.
6. Patients with concurrent malignancies or other malignancies within 5 years before enrollment.
7. History of allogeneic organ transplantation.
8. Severe dysfunction of the heart, kidney, or other organs.
9. Severe clinically active infection > grade 2 according to NCI-CTC v5.0.
10. Psychiatric illness that may affect the informed consent process; Inability to take oral medications; Participation in another drug clinical trial within 12 months before enrollment.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Zhejiang Cancer HospitalOTHER

jmlyc@21cn.com+86 13322888181

xkliulang1314@163.com+86 13545874189

gjteng@seu.edu.cn+86 0571 - 88122222

jjstcty@sina.com+86 0578-2285888

a88960317@163.com+86 13857877137