Clinical trial · Interventional
HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma
A Single-arm, Prospective Study of HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma
NCT06239532CI-TRIAL-00082811active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 single center, single arm, phase II, prospective study to evaluate the safety and effectiveness of HAIC combined with TAE plus an ICI and an TKI in adult patients (aged ≥18 years) with unresectable intrahepatic cholangiocarcinoma.
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 | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HAIC+TAE | Drug | — | UNRESOLVED |
| Surufatinib | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAE+HAIC+Tislelizumab+Surufatinib
- description
- Patients will receive hepatic arterial infusion chemotherapy (HAIC) sequential transcatheter arterial embolization(TAE) combined with Tislelizumab and Surufatinib
- interventionNames
- Drug: HAIC+TAE
- Drug: Tislelizumab
- Drug: Surufatinib
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 24 months
- description
- the sum of complete response rate and partial response rate
Secondary outcomes (6)
- measure
- Progression-free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent for the trial. 2. Aged ≥18 years. 3. Histologically confirmed intrahepatic cholangiocarcinoma. 4. No other previous systematic treatment for BTC. 5. At least one measurable lesion (RECIST 1.1). 6. Eastern Cooperative Oncology Group performance status 0 or 1. 7. Life expectancy of 3 months or greater. 8. Child-Pugh classification score ≤7. Exclusion Criteria: 1. Recurrent patients. 2. Eastern Cooperative Oncology Group performance status ≥ 2. 3. Life expectancy of less than 3 months. 4. Child-Pugh classification score \> 8. 5. History of hepatic encephalopathy or liver transplantation. 6. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. 7. Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage. 8. Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus. 9. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-CTLA4, etc.). 10. History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis. 11. The researcher considers it inappropriate to enter this study.
References
Publications (2)
- DERIVEDBlair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085. PMID 40812353
- DERIVEDLi KS, Liu Y, Zhang TZ, Xu YF, Zhang ZL. Protocol of REACH-01: a single-arm, open label, prospective study of HAIC sequential TAE combined with tislelizumab and surufatinib in unresectable intrahepatic cholangiocarcinoma. Front Pharmacol. 2024 Nov 18;15:1435639. doi: 10.3389/fphar.2024.1435639. eCollection 2024. PMID 39624833