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| Name | Class |
|---|---|
| BeiGene | INDUSTRY |
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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.
Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of increasing local drug concentration and reducing systemic toxic and side effects. All patients were treated with HAIC (Oxaliplatin and Raltitrexed ). Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each timeï¼› Tislelizumab was given 200mg every 3 weeks. The treatment continued until the patient developed the disease or met the other criteria for terminating the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAE+HAIC+Tislelizumab+Surufatinib | Experimental | Patients will receive hepatic arterial infusion chemotherapy (HAIC) sequential transcatheter arterial embolization(TAE) combined with Tislelizumab and Surufatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAIC+TAE | Drug | Procedure: HAIC+TAE After successful percutaneous hepatic artery cannulation for continuous pumping of drugs. Oxaliplatin(85 mg/m2); Raltitrexed (3 mg/m2) ，continuous infusion for 3 hours. HAIC was performed at an interval of at least 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | the sum of complete response rate and partial response rate | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time from randomization to disease progression | 24 months |
| Conversion to surgical resection rate | Defined as the proportion of patients who were successfully converted to radical resection with negative hepatic margins after the study treatment regimen was calculated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zongli Zhang | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40812353 | Derived | Blair 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. | |
| 39624833 | Derived | Li 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. |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| C000717729 | surufatinib |
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| Tislelizumab | Drug | Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks |
|
| Surufatinib | Drug | Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time. |
|
| 3 months |
| Overall survival (OS) | Time from randomization to death for any cause | 24 months |
| 1-year overall survival rate | one year overall survival rate | 12 months |
| Disease Control rate (DCR) | the sum of complete response rate, partial response rate and stable disease rate | 24 months |
| Incidence rate of adverse events | Defined as the proportion of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 | 24 months |
| D009369 | Neoplasms |