Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT05124002
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2021-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for 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': 'C410216', 'term': 'Folfox protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'HAIC (FOLFOX) + H101'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-01', 'studyFirstSubmitDate': '2021-10-31', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to 1 month', 'description': 'The median amount of time from registration until disease progression or death, whichever occurs first. Disease progression was assessed via RECIST 1.1 criteria.'}], 'secondaryOutcomes': [{'measure': '1 year survival rate', 'timeFrame': '1 year', 'description': 'The percentage of participants who are alive one year after the start of the treatment.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'up to 1month', 'description': 'The percentage of participants who have achieved either a complete or partial response, as assessed by Response Criteria in Solid Tumors (RECIST 1.1).'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'up to 1 month', 'description': 'The percentage of participants who have achieved complete response, partial response and stable disease, as assessed by Response Criteria in Solid Tumors (RECIST 1.1).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oncolytic virus', 'intrahepatic mass-forming cholangiocarcinoma'], 'conditions': ['Cholangiocarcinoma, Intrahepatic']}, 'descriptionModule': {'briefSummary': 'Oncolytic viruses can selectively replicate in and destroy tumor cells. Recent studies indicate that recombinant human adenovirus type 5 (H101), which is the first approved oncolytic virus drug in the world, shows anti-tumor effects on liver cancer. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with HAIC in the treatment of intrahepatic mass-forming cholangiocarcinoma.', 'detailedDescription': "This is a perspective, single-arm trial. According to previous studies, the PFS of HAIC for unresectable intrahepatic cholangiocarcinoma is approximately 8 - 10 months, and one year progression free rate is about 40%. We assumed that the study could detect 20% absolute difference and 1 year PFS rate could achieve 60% PFS by (FOLFOX + H101) over conventional HAIC (FOLFOX). Simon's two-stage design is used to estimate the sample size, with α value of 0.05 and power of 0.9. A total sample size of 66 participants are required."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years, male or female\n* Histologically or cytologically confirmed intrahepatic mass-forming cholangiocarcinoma (IMCC) with unresectable lesion(s) or patients who refuse surgery\n* At least one measurable lesion according RECIST v1.1 criteria \\[spiral CT/MRI scan ≥ 10 mm (CT scan slice thickness no greater than 5 mm)\\]\n* Life expectancy ≥ 3 months\n* The function of vital organs meets the following requirements: absolute neutrophil count (ANC) ≥ 3.5 × 10\\^9/L; platelets ≥ 125 × 10\\^9/L; hemoglobin ≥ 8 g/dL; Serum albumin ≥ 2.8 g/dL; bilirubin ≤ 3 ULN, ALT/AST ≤ 2.5 ULN; ALT/AST in the presence of liver metastases ≤ 5 ULN; creatinine ≤ 1.5 ULN; euthyroid; LVEF \\> 50%\n* The date of the first dose of study drug is ≥ 21 days from the date of previous anti-tumor treatment, and has recovered from adverse reactions to prior anti-tumor therapy to baseline or lower than grade 1 (according to CTCAE Version 5.0)(except alopecia)\n* Female patients of childbearing potential (including early menopause, menopause \\< 2 years, and non-surgical sterilization), male patients and their partners must agree to use effective contraceptive measures during the study\n* Patients or their legal representatives can understand and offer informed consent, being willing to take part in the follow-up with good compliance\n\nExclusion Criteria:\n\n* Pregnant or lactating women, men or women who are reluctant to take effective contraceptive measures\n* Previous treatment with oncolytic viruses (such as T-VEC)\n* Abnormal coagulation function, or having a bleeding tendency, or receiving thrombolytic or anticoagulant therapy\n* Patients with poor glycemic control\n* Known central nervous system tumors, including metastatic brain tumors\n* Accompanied by any unstable systemic diseases, including but not limited to severe infection, resistant hypertension, unstable angina, stroke or myocardial infarction within 6 months, congestive heart failure, and serious cardiac arrhythmia requiring medication, renal or metabolic disease requiring medication\n* Known hypersensitivity to the study drug or oxaliplatin, leucovorin calcium, fluorouracil\n* History of immunodeficiency or autoimmune disease, or receiving long-term systemic steroid therapy within 7 days before enrollment, or any form of immunosuppressive therapy\n* Other conditions that are not suitable for participating in this trial'}, 'identificationModule': {'nctId': 'NCT05124002', 'briefTitle': 'Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tsinghua Chang Gung Hospital'}, 'officialTitle': 'Recombinant Human Adenovirus Type 5 Combined With Hepatic Artery Infusion Chemotherapy of FOLFOX in Patients With Intrahepatic Mass-forming Cholangiocarcinoma: a Single-site, Single-arm, Prospective Study', 'orgStudyIdInfo': {'id': '21325-2-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'H101+HAIC', 'description': 'Recombinant Human Adenovirus Type 5 (H101): intratumorally injected 3 days before HAIC. 1 vial (5.0 × 10\\^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10\\^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10\\^12 vp) if the maximum diameters of lesion is \\> 10 cm.\n\nHAIC (FOLFOX): Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium', 'interventionNames': ['Drug: Recombinant Human Adenovirus Type 5', 'Drug: HAIC of FOLFOX']}], 'interventions': [{'name': 'Recombinant Human Adenovirus Type 5', 'type': 'DRUG', 'otherNames': ['H101'], 'description': 'H101 will be intratumorally injected 3 days before HAIC. Dosage of H101: 1 vial (5.0 × 10\\^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10\\^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10\\^12 vp) if the maximum diameters of lesion is \\> 10 cm.', 'armGroupLabels': ['H101+HAIC']}, {'name': 'HAIC of FOLFOX', 'type': 'DRUG', 'otherNames': ['FOLFOX'], 'description': "Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium. The infusion will be continued for 2-3 days according to patients' tolerance and tumor conditions. The standard treatment for HAIC consists of 4-6 cycles, with the second cycle being 3 weeks after the end of the first HAIC cycle and the subsequent cycles being 4 weeks after the end of the previous HAIC.", 'armGroupLabels': ['H101+HAIC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102218', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Tianxiao, MD', 'role': 'CONTACT', 'email': 'wtx419@163.com', 'phone': '+86 13969193950'}], 'facility': 'Beijing Tsinghua Chang Gung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wang Tianxiao, MD', 'role': 'CONTACT', 'email': 'wtx419@163.com', 'phone': '0086-13969193950'}], 'overallOfficials': [{'name': 'ZHANG YUEWEI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tsinghua Chang Gung Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tsinghua Chang Gung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}