Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-03-03 @ 6:47 PM
Study NCT ID:
NCT06849193
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2025-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 332}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2025-02-23', 'studyFirstSubmitQcDate': '2025-02-23', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival(OS)', 'timeFrame': 'up to approximately 2 years', 'description': 'The OS is defined as the time from the initiation of any combination treatment to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)', 'timeFrame': 'up to approximately 2 years', 'description': 'The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1, mRECIST and iRECIST) or death due to any cause, whichever occurs first.'}, {'measure': 'Objective response rate(ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)', 'timeFrame': 'up to approximately 2 years', 'description': 'The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1, mRECIST and iRECIST.'}, {'measure': 'Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1, modified Response Evaluation Criteria in Solid Tumors and immune-modified Response Evaluation Criteria In Solid Tumors(RECIST 1.1, mRECIST and iRECIST)', 'timeFrame': 'up to approximately 2 years', 'description': 'DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RECIST 1.1, mRECIST and iRECIST.'}, {'measure': 'Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0', 'timeFrame': 'up to approximately 2 years', 'description': 'The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Unresectable Biliary Tract Cancer', 'immunotherapy', 'Dynamic prediction model', 'systemic chemotherapy'], 'conditions': ['Unresectable Biliary Tract Cancer', 'Dynamic Prediction Model', 'Immunotherapy']}, 'descriptionModule': {'briefSummary': 'This study focused on the longitudinal tumor burden profile (tumor macro features, histopathological types and imaging features, etc.), liver function, health status, tumor biomarkers, and serological indicators of patients with unresectable biliary malignancies before chemotherapy combined with immunotherapy to build a dynamic prediction model. Based on this model, risk stratification of BTC patients was realized to explore which specific populations could safely initiate combination therapy. By constructing a risk stratification model, it can help clinicians to screen the best treatment population and provide a basis for safe treatment of high-risk patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population of this project is patients diagnosed with unresectable biliary malignancies and treated with systemic chemotherapy combined with immunosuppressive agents.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Confirmed by histopathological diagnosis and/or clinical diagnosis (typical imaging features, clinical manifestations, laboratory examination, etc.) as biliary malignancy (Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Biliary malignancy (2024)); 2. Based on unresectable malignant tumor in the diagnosis of biliary and in patients undergoing chemotherapy with immunosuppressant therapy system; 3. The liver function class for Child - Pugh, A or B; 4. More than 18 years of age, gender not limited; 5. Expected survival time for 3 months or more; 6. ECOG PS score 2 or less; 7. Meet the following laboratory test parameters:\n\n 1. Hematological system function: Absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L; hemoglobin ≥ 90 g/L; international normalized ratio less than 1.7 or prothrombin time prolongation not exceeding 4 seconds.\n 2. Liver function: Alanine aminotransferase/aspartate aminotransferase not exceeding 5 times the upper limit of normal; total bilirubin ≤ 210 μmol/L \\[≤ 2.38 mg/dL\\]; albumin ≥ 28 g/L.\n 3. Renal function: Serum creatinine not exceeding 1.5 times the upper limit of normal.\n\nExclusion Criteria:\n\n* Malignant tumors other than BTC;\n* Moderate to severe ascites (ascites reaching a Child-Pugh score of 3);\n* Any local treatment (including transcatheter interventional therapy, ablation therapy, internal/external radiotherapy, etc.) or surgical resection or traditional Chinese medicine within 4 weeks before the combination of systemic chemotherapy and immunotherapy;\n* Incomplete data, such as incomplete laboratory test data, missing or poor-quality imaging data, or lack of prognostic information;\n* Severe liver dysfunction, such as decompensated cirrhosis and other liver diseases that significantly affect bilirubin levels;\n* Severe comorbidities, such as refractory hypertension (blood pressure still higher than 150/100 mm Hg after optimal drug treatment), persistent arrhythmia (CTCAE grade 2 or above), any degree of atrial fibrillation, prolonged QTc interval (more than 450 milliseconds in men and more than 470 milliseconds in women), renal insufficiency, etc.;\n* Human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome;\n* Pregnant or lactating women;\n* Acute or chronic mental disorders (including mental disorders that affect the subject's enrollment, treatment intervention, and follow-up)."}, 'identificationModule': {'nctId': 'NCT06849193', 'acronym': 'BTCICTY-001', 'briefTitle': 'Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study', 'orgStudyIdInfo': {'id': '2024040196'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Systemic chemotherapy combined with immunotherapy', 'type': 'DRUG', 'description': "The electronic medical record system was used to collect patients' basic information and treatment plan information, including treatment plan, administration cycle, administration date, administration dose, frequency, number of cycles, efficacy, adverse reactions, etc."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gao-Jun Teng, M.D', 'role': 'CONTACT', 'email': 'gjteng@vip.sina.com', 'phone': '+86-02583272121'}], 'facility': 'Zhongda Hospital,', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Zhongda Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Gao-Jun Teng, M.D', 'role': 'CONTACT', 'email': 'gjteng@vip.sina.com', 'phone': '+86-02583272121'}], 'overallOfficials': [{'name': 'Gao-Jun Teng, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda hospital, Southeast university, Nanjing, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongda Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'The Third Affiliated Hospital of Soochow University', 'class': 'OTHER'}, {'name': 'Jiangsu Cancer Institute & Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital, University of Science and Technology of China', 'class': 'OTHER'}, {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, {'name': 'Yunnan Cancer Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of interventional and Vascular Surgery Department', 'investigatorFullName': 'Gao-jun Teng', 'investigatorAffiliation': 'Zhongda Hospital'}}}}