Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT04902261
Status:
UNKNOWN
Last Update Posted:
2023-09-01
First Post:
2021-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'D013660', 'term': 'Taxes'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-Year Survival Rates', 'timeFrame': 'Up to 2 years', 'description': 'The proportion of patients who survive more than 1 year after treatment.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate（ORR)', 'timeFrame': 'Up to 2 years', 'description': 'the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR)'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'The time from the date of treatment to the first of either disease progression, relapse or death'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 2 years', 'description': 'The time from the date of treatment start to the date of death or to the date of last follow-up for patients alive'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'Up to 2 years', 'description': 'the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0; Surgical safety including Intraoperative blood loss，PHLF assessed by ISGLS（2012），Postoperative complications evaluated by modified Clavien-Dindo system.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer', 'detailedDescription': 'There is heterogeneity in desmoplasia between different metastatic sites in pancreatic cancer. The tumor quasi-characteristics of patients with metastatic PDAC at presentation were more obvious than those of epithelial characteristics, and the quasi-and epithelial subtypes showed different responses to chemotherapy regimens, and the epithelial phenotype tumor quasi-phenotype was associated with metastasis-free survival. Therefore, different metastases of pancreatic cancer may respond differently to medical treatment. There were different metastases after postoperative recurrence of pancreatic cancer, 25.2% had only liver metastases, 14.7% had only lung metastases, 14.7% had multiple distant metastases, and about more than half of the patients had postoperative recurrence with only distant metastases and no in situ metastasis. Then whether there is a difference in the efficacy of PD1 drug therapy in patients with different metastases needs to be further verified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with radiologically or histologically confirmed postoperative Recurrent Pancreatic Cancer\n* Patients with at least one measurable lesion (according to RECIST 1.1 criteria);\n* Have not received gemcitabine-based regimen after surgery\n* No systemic treatment after diagnosis of recurrence\n* ECOG score 0-1\n* Expected survival ≥ 3 months;\n* Liver function is essentially normal: absolute neutrophil count \\> 1500/mm ³; platelet count \\> 100,000/mm ³; creatinine less than 1.5 times the upper limit of normal or calculated creatinine clearance (CRCI) \\> 45 mL/min; total bilirubin ≤ 2.0 mg/dL; aspartate aminotransferase (AST) and alanine aminotransferase less than 2.5 times the upper limit of normal\n* Appropriate to participate in this trial as assessed by the investigator before entering the study\n* Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* Patients who only undergo abdominal laparotomy but do not undergo resection of pancreatic tumor tissue\n* Received gemcitabine-based regimen after surgery\n* Systemic treatment after diagnosis of recurrence\n* Patients with previous allergic reactions to similar drugs\n* Pregnant or lactating patients\n* Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening (including detectable ascites or ascites requiring puncture and aspiration on physical examination at screening)\n* History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc\n* Patients with severe cardiovascular diseases within 12 months before enrollment, such as symptomatic coronary heart disease, ≥ grade II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, etc\n* Presence of any active immunodeficiency or autoimmune disease and/or history of any immunodeficiency or autoimmune disease that may recur at screening (e.g., hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc)\n* Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment\n* Patients with other previous malignancies who are not cured\n* Immunodeficient patients, such as HIV-positive\n* Uncontrollable psychosis'}, 'identificationModule': {'nctId': 'NCT04902261', 'briefTitle': 'Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CHEC2020-144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tislelizumab combined with Nab-paclitaxel and Gemcitabine', 'interventionNames': ['Drug: Tislelizumab', 'Drug: Nab paclitaxel', 'Drug: Gemcitabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nab-paclitaxel and Gemcitabine', 'interventionNames': ['Drug: Nab paclitaxel', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'Tislelizumab', 'type': 'DRUG', 'description': 'Tislelizumab 200 mg every three weeks', 'armGroupLabels': ['Tislelizumab combined with Nab-paclitaxel and Gemcitabine']}, {'name': 'Nab paclitaxel', 'type': 'DRUG', 'description': 'Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks', 'armGroupLabels': ['Nab-paclitaxel and Gemcitabine', 'Tislelizumab combined with Nab-paclitaxel and Gemcitabine']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine 1000mg/m2 on d1 and d8 every three weeks', 'armGroupLabels': ['Nab-paclitaxel and Gemcitabine', 'Tislelizumab combined with Nab-paclitaxel and Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiwei Guo, Doctor', 'role': 'CONTACT', 'email': 'gestwa@163.com', 'phone': '+8618621500666'}, {'name': 'Gang Jin, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shiwei Guo, Doctor', 'role': 'CONTACT', 'email': 'gestwa@163.com', 'phone': '+8618621500666'}], 'overallOfficials': [{'name': 'Gang Jin, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Guo ShiWei', 'investigatorAffiliation': 'Changhai Hospital'}}}}