Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-27 @ 3:07 AM
Study NCT ID:
NCT06988592
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'A baseline tumor biopsy and blood collection before initiation of treatment, followed by a second tumor biopsy with paired blood collection after the first response evaluation will be planned.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-16', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1', 'timeFrame': 'max 42 months', 'description': 'OS is defined as the time from study treatment to the date of death of the subject, regardless of the cause of death.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1', 'timeFrame': 'max 24 months', 'description': 'ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.'}, {'measure': 'Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1', 'timeFrame': 'max 24 months', 'description': 'DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD).'}, {'measure': 'Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1', 'timeFrame': 'max 24 months', 'description': 'DOR is defined as the time from first documented complete or partial response until disease progression, death from any cause, or censoring at date of last tumor assessment.'}, {'measure': 'Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1', 'timeFrame': 'max 24 months', 'description': 'TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed'}, {'measure': 'Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1', 'timeFrame': 'max 24 months', 'description': 'PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first)'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'max 42 months', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.'}, {'measure': 'Translational study', 'timeFrame': 'max 24 months', 'description': 'Proportion of different immune cell types in tumors and blood based on RNA sequencing between two groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Biliary Tract Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (BTC) patients receiving first-line standard therapy with gemcitabine/cisplatin (GemCis) combined with PD-1/PD-L1 inhibitors.', 'detailedDescription': 'This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (BTC) patients receiving first-line standard therapy with gemcitabine/cisplatin (GemCis) combined with PD-1/PD-L1 inhibitors. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in treatment-naïve advanced biliary tract cancer (BTC) patients receiving first-line standard therapy with gemcitabine/cisplatin (GemCis) combined with PD-1/PD-L1 inhibitors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed unresectable/metastatic cholangiocarcinoma (intrahepatic, extrahepatic, or gallbladder).\n* No prior systemic anticancer therapy (chemotherapy, targeted therapy, or immunotherapy).\n* Planned to receive GemCis+PD-1/PD-L1 inhibitor as standard first-line treatment.\n* ≥1 measurable lesion per RECIST 1.1.\n* ECOG performance status 0-1.\n* Adequate organ function:\n\n * ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL.\n * Total bilirubin ≤1.5 × ULN, AST/ALT ≤3 × ULN (≤5 × ULN if liver metastases).\n * Creatinine ≤1.5 × ULN or CrCl ≥60 mL/min.\n* Willing to provide archival/fresh tumor tissue and peripheral blood samples.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Prior systemic therapy.\n* Active autoimmune disease requiring immunosuppression.\n* Active infection requiring IV antibiotics.\n* HIV-positive or active HBV/HCV infection (HBsAg+ with HBV DNA ≥2000 IU/mL; HCV RNA+).\n* Symptomatic CNS metastases.\n* Pregnancy/lactation.\n* Any condition compromising protocol compliance or data interpretation per investigator.'}, 'identificationModule': {'nctId': 'NCT06988592', 'acronym': 'BTC-IM-1', 'briefTitle': 'GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1）', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective, Non-interventional Study of Gemcitabine/Cisplatin Combined With PD-1/PD-L1 Inhibitor as First-line Treatment in Treatment-naïve Advanced Biliary Tract Cancer Patients: Efficacy and Immune Microenvironment Dynamics', 'orgStudyIdInfo': {'id': 'BTC-IM-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BTC cohort', 'interventionNames': ['Drug: GemCis plus PD-1/PD-L1 inhibitor']}], 'interventions': [{'name': 'GemCis plus PD-1/PD-L1 inhibitor', 'type': 'DRUG', 'description': 'Gemcitabine: 1000 mg/m², intravenous infusion, on Day 1 and Day 8 Cisplatin: 25 mg/m², intravenous infusion, on Day 1 and Day 8 PD-1/PD-L1 inhibitor: An approved agent (e.g., Pembrolizumab, Nivolumab, Atezolizumab, etc.) will be selected based on clinical practice and administered at standard doses and schedules.\n\nEach treatment cycle lasts 21 days, continuing until disease progression, unacceptable toxicity, or patient/physician decision to discontinue.', 'armGroupLabels': ['BTC cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Wang', 'role': 'CONTACT', 'email': 'peng_wang@fudan.edu.cn', 'phone': '+86021-64041990'}], 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Peng Wang, MD', 'role': 'CONTACT', 'email': 'peng_wang@fudan.edu.cn', 'phone': '86-21-64041990'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Peng Wang', 'investigatorAffiliation': 'Fudan University'}}}}