Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-01-06 @ 8:32 AM
Study NCT ID:
NCT07263360
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2025-11-23', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R0 Resection Rate', 'timeFrame': 'up to 12 month'}], 'secondaryOutcomes': [{'measure': 'Conversion Rate', 'timeFrame': 'up to 12 month'}, {'measure': 'Objective response rate', 'timeFrame': 'up to 12 month', 'description': 'the percentage of participants in the analysis population who had a CR(Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) usingRECIST 1.1 based on investigator assessment.'}, {'measure': 'Progression-Free Survival', 'timeFrame': 'up to 12 month', 'description': 'PFS was defined as the time from first dose of study treatment to the firstdocumented PD per REClST 1.1 by investigator assessment, or death due to any cause, whicheveroccurred first.'}, {'measure': 'pathological Complete Response', 'timeFrame': 'up to 12 month'}, {'measure': 'Overall survival', 'timeFrame': 'up to 36 month', 'description': 'OS was defined as the time from the first dose of study drug to death due to any cause.'}, {'measure': 'Adverse Events', 'timeFrame': 'up to 36 month', 'description': 'An AE was defined as any untoward medical occurrence in a pharmaceutical productwhich does not necessarily have to have a causal relationship with this treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lparomlimab and Tuvonralimab injection', 'GemOX', 'Lenvatinib'], 'conditions': ['BTC']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) combined with GemOX and lenvatinib as conversion therapy for Initially Potentially Resectable intrahepatic cholangiocarcinoma and gallbladder cancer.', 'detailedDescription': 'This single-arm, single-center clinical study aims toevaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) combined with GemOX and lenvatinib as conversion therapy for Initially Potentially Resectable intrahepatic cholangiocarcinoma and gallbladder cancer. This study consists of three phases: screening, treatment, and follow-upEfficacy evaluation and safety monitoring should be performed throughout the study.'}, '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 diagnosis of locally advanced or potentially resectable intrahepatic cholangiocarcinoma or gallbladder cancer, defined as T2b-T4 or N1 M0 according to the AJCC 8th edition.\n* Expected life expectancy ≥ 12 weeks.\n* No prior systemic treatment for biliary tract cancer before the first dose of study medication.\n* At least one measurable lesion as defined by RECIST 1.1 criteria.\n* ECOG Performance Status of 0 or 1.\n* Adequate organ function, without severe dysfunction of the hematologic, cardiac, pulmonary, hepatic, renal, bone marrow, or immune systems.\n* Laboratory tests meeting the following requirements: Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug. For men, they must be surgically sterile or agree to use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug.\n* Patient voluntarily participates and provides written informed consent.\n* Good compliance is anticipated, allowing for efficacy and adverse event follow-up per the protocol.\n\nExclusion Criteria:\n\n* The subject has received any prior antitumor therapy or any investigational anticancer agents.\n* Presence of any active autoimmune disease or a history of autoimmune diseases (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \\[may be enrolled if stable on hormone replacement therapy\\]). Patients with childhood asthma that has completely resolved in adulthood without any intervention, or vitiligo, may be enrolled. Patients requiring medical intervention with bronchodilators are not eligible.\n* Known congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection.\n* Uncontrolled cardiac clinical symptoms or diseases, e.g., NYHA Class II or above heart failure, unstable angina, myocardial infarction within 1 year, or patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n* Severe concurrent infection within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever \\>38.5°C during screening/prior to the first dose.\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Administration of a live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study period.\n* History of or concurrent other malignant tumors within the past 5 years (except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ovarian cancer).\n* Gastrointestinal bleeding event or active hemoptysis within 28 days prior to the first dose.\n* Gastric or esophageal varices requiring treatment.\n* Active malignant tumors within 36 months prior to enrollment.\n* Known allergy to any of the investigational drug components.\n* Poorly controlled psychiatric disorder.\n* Presence of superior mesenteric vein tumor thrombus, metastasis to group 16 lymph nodes, or distant metastasis to other organs / biological factors: peritoneal metastasis, direct invasion to adjacent organs, etc. / involvement of organs (pancreas, stomach, duodenum, colon) that cannot be resected en bloc.\n* Any other condition deemed by the investigator as unsuitable for enrollment. This includes, but is not limited to, pre-existing central nervous system metastases, severe laboratory abnormalities, or familial/social factors that could compromise the subject's safety, or data/sample collection.\n* Patients with extensive liver metastases involving the entire liver."}, 'identificationModule': {'nctId': 'NCT07263360', 'briefTitle': 'Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'A Single-arm, Single-center Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer', 'orgStudyIdInfo': {'id': 'E20251152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib', 'description': 'Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib', 'interventionNames': ['Drug: Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib']}], 'interventions': [{'name': 'Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib', 'type': 'DRUG', 'description': 'Iparomlimab and Tuvonralimab Injection:5 mg/kg, intravenous infusion on Day 1 of each 3-week cycle (q3w); for 4 to 6 cycles.\n\nLenvatinib: 8-12 mg, orally once daily (qd). The dose is determined by body weight:8 mg po qd for body weight \\< 60 kg;12 mg po qd for body weight ≥ 60 kg\n\nGemOX Regimen:\n\nOxaliplatin: 85 mg/m², intravenous infusion on Day 1 of each 3-week cycle (q3w); for a maximum of 6 cycles.\n\nGemcitabine: 1000 mg/m², intravenous infusion on Day 1 and Day 8 of each 3-week cycle (q3w); for a maximum of 6 cycles.\n\nPostoperative Treatment for Patients with Successful Conversion:\n\nIparomlimab and Tuvonralimab Injection: 5 mg/kg, intravenous infusion on Day 1 of each 3-week cycle (q3w); for 8 cycles.\n\nFor Patients without Successful Conversion:\n\nSubsequent treatment regimens will be determined by the investigator.', 'armGroupLabels': ['Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300000', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Wei Zhang', 'role': 'CONTACT', 'email': 'zhangweitjch@163.com', 'phone': '18526812877'}], 'facility': 'Tianjin Medical University Cancer Institute and Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Wei Zhang', 'role': 'CONTACT', 'email': 'zhangweitjch@163.com', 'phone': '+86 18622025401'}, {'name': 'Wen X Liu', 'role': 'CONTACT', 'email': 'liuwenxiao2016@outlook.com', 'phone': '18515456035'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}