Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT03983057
Status:
UNKNOWN
Last Update Posted:
2023-06-13
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Anti-PD-1 Antibody and Chemotherapy in 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': 'C000711728', 'term': 'spartalizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 830}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-08', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'Through the study peirod, for 3 years', 'description': 'The time of treatment until documented tumor progreesion.'}], 'secondaryOutcomes': [{'measure': 'Resection rate', 'timeFrame': 'Through the study peirod, for 3 years', 'description': 'The proportion of patients with surgeical treatment after treatment'}, {'measure': 'R0 rate', 'timeFrame': 'Through the study peirod, for 3 years', 'description': 'The proportion of patients with completely tumor resection after treatment'}, {'measure': 'Objective response rate', 'timeFrame': 'Through the study peirod, for 3 years', 'description': 'The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period'}, {'measure': 'Disease control rate', 'timeFrame': 'Through the study peirod, for 3 years', 'description': 'The proportion of patients with tumor size reduction or stable'}, {'measure': 'Overall survival', 'timeFrame': 'Through the study peirod, for 3 years', 'description': 'The time of treatment until death.'}, {'measure': 'EORTC QLQ - PAN26 score', 'timeFrame': 'Through the study peirod, for 3 years', 'description': 'QLQ score assessed by the European Organization for Research and Treatment of Cancer Quality of Life scale for pancreatic cancer'}, {'measure': 'Adverse effects', 'timeFrame': 'Through the study peirod, for 3 years', 'description': 'The most common hematologic and non-hemotologic adverse events'}, {'measure': 'Carbohydrate antigen 19-9', 'timeFrame': 'Through the study peirod, for 3 years', 'description': 'Carbohydrate antigen 19-9 level'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic cancer', 'PD-1', 'FOLFIRINOX', 'combination therapy'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with borderline resectable and locally advanced pancreatic cancer.', 'detailedDescription': "Investigators chose borderline resectable and locally advanced pancreatic cancer patients. The planned treatment was given to the participants after randomization. Response rate, recurrence-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with borderline resectable and locally advanced pancreatic cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).\n* No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.\n* Initial assessment for definitive borderline resectable or locally advanced tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2019 first edition standard).\n* ECOG score 0 or 1.\n* Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.\n* ALT and AST are less than 2 x ULN.\n* If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.\n* Leukocyte count (\\> 3.5 x 10\\^6 /mL), neutrophil count (\\> 1.5 x 10\\^6 /mL), platelet count (\\> 80 x 10\\^6 /mL), hemoglobin (\\> 9 g/dL).\n* Signed informed consent.\n\nExclusion Criteria:\n\n* History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma\n* History of participation of other clinical trails within 4 weeks\n* History of immunotherapy within 4 weeks\n* History of receiving chemotherapy, radiotherapy and molecular target therapy within 2 weeks\n* Tumor is a local recurrent lesion.\n* Imaging confirmed severe portal hypertension / cavernous transformation.\n* Ascites\n* Gastric outlet obstruction\n* Respiratory failure requires supplementation of oxygen.\n* Immune deficiency syndrome, such as active tuberculosis and HIV infection.\n* Hematological precancerous diseases, such as myelodysplastic syndromes.\n* Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.\n* Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings\n* Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)\n* Preexisting neuropathy \\> 1 (NCI CTCAE).\n* Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.\n* Severe serious wounds, ulcers or fractures.\n* Confirmed coagulant disease.\n* Clinical evaluation is unacceptable.'}, 'identificationModule': {'nctId': 'NCT03983057', 'briefTitle': 'Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Study on Therapeutic Effect of Combination of Anti-PD-1 Antibody and Chemotherapy in Locally Advanced or Borderline Resectable Pancreatic Cancer Patients: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CISPD-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Chemotherapy group', 'description': 'Treatment with modified-FOLFIRINOX Folic acid 400mg/m\\^2, 5- fluorouracil 2400mg/m\\^2 for 46h, irinotecan 135mg/m\\^2 and oxaliplatin 68mg/m\\^2'}, {'type': 'EXPERIMENTAL', 'label': 'Combination group', 'description': 'Treatment with modified-FOLFIRINOX and Anti-PD-1 antibody Folic acid 400mg/m\\^2, 5- fluorouracil 2400mg/m\\^2 for 46h, irinotecan 135mg/m\\^2 and oxaliplatin 68mg/m\\^2, Anti-PD-1 antibody 3mg/kg', 'interventionNames': ['Drug: Anti-PD-1 monoclonal antibody']}], 'interventions': [{'name': 'Anti-PD-1 monoclonal antibody', 'type': 'DRUG', 'description': 'Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.', 'armGroupLabels': ['Combination group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang TingBo, MD, PHD', 'role': 'CONTACT', 'email': 'liangtingbo@zju.edu.cn', 'phone': '086-571-87236688'}], 'facility': 'the First Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Tingbo Liang, MD PhD', 'role': 'CONTACT', 'email': 'liangtingbo@zju.edu.cn', 'phone': '8613666676128'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'TingBo Liang', 'investigatorAffiliation': 'Zhejiang University'}}}}