Clinical trial · Interventional
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma (Icc) | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Hepatic Arterial Infusion Chemotherapy | Procedure | — | UNRESOLVED |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
| Transcatheter Arterial Chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TACE Plus Tislelizumab and Lenvatinib
- description
- Participants will receive tislelizumab 200 mg intravenously every 3 weeks and oral lenvatinib once daily at a starting dose of 12 mg for body weight ≥60 kg or 8 mg for body weight \<60 kg. TACE will be performed after initiation of lenvatinib and may be repeated based on radiologic response, residual viable tumor, liver function, and investigator assessment. Both conventional TACE (cTACE) and drug-eluting beads TACE are allowed, and hepatic artery infusion chemotherapy may be added at investigator's discretion. Treatment will continue until clinical progression, radiologic progressive disease according to RECIST v1.1, completion of 2 years of immunotherapy, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria.
- interventionNames
- Drug: Tislelizumab
- Drug: Lenvatinib
- Procedure: Transcatheter Arterial Chemoembolization
- Procedure: Hepatic Arterial Infusion Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine-Cisplatin Plus Tislelizumab
- description
- Participants will receive cisplatin 25 mg/m² on Day 1 and Day 8, gemcitabine 1000 mg/m² on Days 1 and 8, and tislelizumab 200 mg on Day 1 of each 3-week cycle for up to 8 cycles. After completion of gemcitabine-cisplatin treatment, participants will continue tislelizumab 200 mg intravenously every 3 weeks. Treatment will continue until clinical progression, radiologic progressive disease according to RECIST v1.1, completion of 2 years of immunotherapy, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available