Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT06239532
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-21
First Post:
2023-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'C000717729', 'term': 'surufatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2023-12-28', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '24 months', 'description': 'the sum of complete response rate and partial response rate'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '24 months', 'description': 'Time from randomization to disease progression'}, {'measure': 'Conversion to surgical resection rate', 'timeFrame': '3 months', 'description': 'Defined as the proportion of patients who were successfully converted to radical resection with negative hepatic margins after the study treatment regimen was calculated'}, {'measure': 'Overall survival (OS)', 'timeFrame': '24 months', 'description': 'Time from randomization to death for any cause'}, {'measure': '1-year overall survival rate', 'timeFrame': '12 months', 'description': 'one year overall survival rate'}, {'measure': 'Disease Control rate (DCR)', 'timeFrame': '24 months', 'description': 'the sum of complete response rate, partial response rate and stable disease rate'}, {'measure': 'Incidence rate of adverse events', 'timeFrame': '24 months', 'description': 'Defined as the proportion of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intrahepatic Cholangiocarcinoma']}, 'referencesModule': {'references': [{'pmid': '39624833', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 time； 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent for the trial.\n2. Aged ≥18 years.\n3. Histologically confirmed intrahepatic cholangiocarcinoma.\n4. No other previous systematic treatment for BTC.\n5. At least one measurable lesion (RECIST 1.1).\n6. Eastern Cooperative Oncology Group performance status 0 or 1.\n7. Life expectancy of 3 months or greater.\n8. Child-Pugh classification score ≤7.\n\nExclusion Criteria:\n\n1. Recurrent patients.\n2. Eastern Cooperative Oncology Group performance status ≥ 2.\n3. Life expectancy of less than 3 months.\n4. Child-Pugh classification score \\> 8.\n5. History of hepatic encephalopathy or liver transplantation.\n6. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.\n7. Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage.\n8. Portal vein tumor thrombus (PVTT) involves both the main trunk and contralateral branch or upper mesenteric vein. Inferior vena cava tumor thrombus.\n9. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-CTLA4, etc.).\n10. History of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.\n11. The researcher considers it inappropriate to enter this study.'}, 'identificationModule': {'nctId': 'NCT06239532', 'briefTitle': 'HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'A Single-arm, Prospective Study of HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma', 'orgStudyIdInfo': {'id': 'REACH-01'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'HAIC+TAE', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['TAE+HAIC+Tislelizumab+Surufatinib']}, {'name': 'Tislelizumab', 'type': 'DRUG', 'description': 'Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks', 'armGroupLabels': ['TAE+HAIC+Tislelizumab+Surufatinib']}, {'name': 'Surufatinib', 'type': 'DRUG', 'description': 'Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.', 'armGroupLabels': ['TAE+HAIC+Tislelizumab+Surufatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Zongli Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'BeiGene', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhang Zongli', 'investigatorAffiliation': 'Qilu Hospital of Shandong University'}}}}