Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 5:41 PM
Study NCT ID:
NCT07099794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '5 years', 'description': 'The time between participant randomization and first recorded disease progression or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Patients were randomized to the time of death from any cause.'}, {'measure': 'Objective Response Rate', 'timeFrame': '5 years', 'description': 'The proportion of participants in the analyzed population with confirmed complete (CR) or partial response (PR) based on RECIST v1.1'}, {'measure': 'Disease control rate', 'timeFrame': '5 years', 'description': 'Percentage of cases with confirmed complete response, partial response, and stable disease (≥ 8 weeks) in patients for whom response could be evaluated.'}, {'measure': 'Adverse events', 'timeFrame': '5 years', 'description': 'Adverse events (AE)/Serious Adverse Events (SAE) (as determined by NCI-CTCAE 5.0).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Tract Cancer (BTC)']}, 'descriptionModule': {'briefSummary': 'This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients voluntarily joined the study and signed the informed consent;\n* Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;\n* Previous first-line combination therapy failed;\n* At least one measurable lesion meets the RECIST v1.1 criteria\n* ECOG PS：0\\~1；\n* Expected survival ≥12 weeks;\n* Essential organ and hematological function;\n* Patients need contraception;\n\nExclusion Criteria:\n\n* The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;\n* Patients had active malignancies other than BTC within 5 years or at the same time.\n* Clinical symptoms or diseases of the heart that are not well controlled;\n* Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);\n* Any clinically significant gastrointestinal disorder, including bleeding, inflammation, occlusion, or diarrhea \\> grade 2;\n* A thrombotic or embolic event occurred within 6 months prior to the start of the study therapy;\n* Use of strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogiaries) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent;\n* Known allergy to the study drug;\n* An uncontrolled infection occurs during screening;\n* Patients with congenital or acquired immune deficiency (e.g., HIV);\n* Have a history of brain metastases or have developed brain metastases;'}, 'identificationModule': {'nctId': 'NCT07099794', 'briefTitle': 'A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}, 'officialTitle': 'Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study', 'orgStudyIdInfo': {'id': 'NCC EC/IRB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NALIRI+Lenvatinib', 'description': 'Liposomal irinotecan+5-FU/LV+Lenvatinib', 'interventionNames': ['Drug: Liposomal irinotecan+5-FU/LV+Lenvatinib']}, {'type': 'EXPERIMENTAL', 'label': 'NALIRI', 'description': 'Liposomal irinotecan+5-FU/LV', 'interventionNames': ['Drug: NALIRI']}], 'interventions': [{'name': 'Liposomal irinotecan+5-FU/LV+Lenvatinib', 'type': 'DRUG', 'description': 'Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w Renvastinib: ≥60kg, 12mg; \\<60kg, 8mg, PO, once daily 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w', 'armGroupLabels': ['NALIRI+Lenvatinib']}, {'name': 'NALIRI', 'type': 'DRUG', 'description': 'Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w', 'armGroupLabels': ['NALIRI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wen Zhang, Doctor', 'role': 'CONTACT', 'email': 'wenwen0605@163.com', 'phone': '+8618611643302'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}