Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-01 @ 1:45 AM
Study NCT ID:
NCT07109167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': '2 years', 'description': 'The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse'}], 'secondaryOutcomes': [{'measure': 'Outcome Measure', 'timeFrame': '3 years', 'description': 'Time from randomization to death from any cause'}, {'measure': 'Objective Response Rate', 'timeFrame': '2 years', 'description': 'It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR)'}, {'measure': 'Quality of life score', 'timeFrame': '3 years', 'description': "Quantitative scoring system for patients' self-subjective self-assessment of current symptom tolerance"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Tract Neoplasms']}, 'descriptionModule': {'briefSummary': 'Evaluate the progression-free survival (PFS) of benmelstobart combined with gemcitabine and cisplatin in first-line patients with advanced cholangiocarcinoma, and the progression-free survival (PFS) of benmelstobart combined with anlotinib in second-line patients with advanced cholangiocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nAge: 18 to 75 years old, inclusive; of either sex. Histopathologically confirmed unresectable and previously untreated gallbladder cancer or intrahepatic/extrahepatic cholangiocarcinoma, with at least one measurable lesion per RECIST v1.1 criteria. Tissue samples must be provided for biomarker analysis, preferably recently obtained tissue. If recent tissue is unavailable, 5-8 archived 5μm-thick paraffin-embedded sections are acceptable.\n\nECOG performance status: 0 or 1. Life expectancy ≥12 weeks.\n\nNormal major organ function, defined as meeting the following criteria:\n\n1. Hematological tests:\n\n 1. Hemoglobin (HB) ≥90 g/L (without blood transfusion within 14 days prior).\n 2. Absolute neutrophil count (ANC) ≥1.5×10⁹/L.\n 3. Platelet count (PLT) ≥80×10⁹/L.\n2. Biochemical tests:\n\n 1. Albumin (ALB) ≥30 g/L (without albumin transfusion within 14 days prior).\n 2. ALT and AST \\<2.5×upper limit of normal (ULN); if liver metastases are present, ALT and AST ≤5×ULN.\n 3. Total bilirubin (TBIL) ≤1.5×ULN.\n 4. Plasma creatinine ≤1.5×ULN; or creatinine clearance (CCr) ≥60 ml/min. Subject voluntarily agrees to participate, signs the informed consent form, and is able to comply with scheduled study visits and procedures.\n\nFemale subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 6 months after treatment completion.\n\nExclusion Criteria Confirmed allergy to any component of Benmelstobart Injection. Uncontrolled hypertension (systolic blood pressure \\>140 mmHg and diastolic blood pressure \\>90 mmHg), coronary heart disease of Grade I or higher, arrhythmia of Grade I or higher (including QTc interval prolongation: males \\>450 ms, females \\>470 ms), or heart failure of Grade I or higher; patients with positive urine protein.\n\nPatients with definite gastrointestinal bleeding tendency, including: active local ulcerative lesions with fecal occult blood test (++); history of melena or hematemesis within 2 months.\n\nCoagulopathy (INR \\>1.5, APTT \\>1.5×ULN) or bleeding tendency. Multiple factors affecting oral drug absorption (e.g., inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).\n\nPatients with central nervous system metastases. Pregnant or lactating women. Patients with other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).\n\nPatients with a history of psychotropic drug abuse who are unable to abstain or with mental disorders.\n\nPatients who participated in other drug clinical trials within 4 weeks. Patients with abnormal thyroid function. Urine protein ≥++ or 24-hour urine protein \\>1.0 g. Radiotherapy to target lesions within 4 weeks prior to the first dose of study treatment.\n\nUse of immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding nasal, inhaled, or other topical glucocorticoids or physiological doses of systemic glucocorticoids (i.e., ≤10 mg/day prednisone or equivalent dose of other glucocorticoids).\n\nAdministration of live attenuated vaccines within 4 weeks prior to the first dose of study treatment or planned during the study period.\n\nMajor surgical procedures (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or unhealed wounds, ulcers, or fractures.\n\nActive, known, or suspected autoimmune disease or history of such diseases within the past 2 years (patients with vitiligo, psoriasis, alopecia, or Graves' disease that did not require systemic treatment in the past 2 years, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy are eligible).\n\nUncontrolled concurrent diseases including but not limited to: HIV infection (HIV antibody positive); active or poorly controlled severe infections.\n\nSymptomatic congestive heart failure (New York Heart Association class II-IV) or symptomatic or poorly controlled arrhythmias.\n\nHistory of interstitial lung disease. Pregnant or lactating female patients. Known history of primary immunodeficiency. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation."}, 'identificationModule': {'nctId': 'NCT07109167', 'briefTitle': 'The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Shandong First Medical University'}, 'officialTitle': 'The Safety and Efficacy of Benmelstobart Injection in Patients With Advanced Biliary Tract Malignant Tumors', 'orgStudyIdInfo': {'id': 'MT-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benmelstobart combined with gemcitabine and cisplatin', 'description': 'Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8;Cisplatin 25mg/m², intravenous infusion on Day 1 and Day 8.\n\nMaintenance dose of study medication:\n\nBenmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8', 'interventionNames': ['Drug: Benmelstobart combined with gemcitabine and cisplatin']}], 'interventions': [{'name': 'Benmelstobart combined with gemcitabine and cisplatin', 'type': 'DRUG', 'description': 'Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8;Cisplatin 25mg/m², intravenous infusion on Day 1 and Day 8. Maintenance dose of study medication: Benmelstobart 1200mg, intravenous infusion on Day 1;Gemcitabine 1000mg/m², intravenous infusion over 30 minutes on Day 1 and Day 8', 'armGroupLabels': ['Benmelstobart combined with gemcitabine and cisplatin']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'peng Jin', 'role': 'CONTACT', 'email': 'kongyingcoco@163.com', 'phone': '13165381171'}], 'overallOfficials': [{'name': 'yan hai Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Shandong First Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Shandong First Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}