Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-01 @ 5:59 AM
Study NCT ID:
NCT05026905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2021-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic 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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D013660', 'term': 'Taxes'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], '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': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best objective response rate (ORR)', 'timeFrame': '6 years', 'description': 'tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.'}], 'secondaryOutcomes': [{'measure': 'Disease control rate (DCR)', 'timeFrame': '6 years', 'description': 'Defined as having complete response, partial response or stable disease at least 12 weeks.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '6 years', 'description': 'from the start date of study treatment to the date of progression disease or death.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '6 years', 'description': 'from the start date of study treatment to the date of death.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '6 years', 'description': 'time from documentation of tumor response to disease progression.'}, {'measure': 'Incidence of Treatment-related Adverse Events [Safety and Tolerability]', 'timeFrame': '6 years', 'description': 'This study will utilize the NCI-CTCAE v5.0 for Adverse Event monitoring and reporting'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic Pancreatic Cancer'], 'conditions': ['Phase II, Open-label, Parallel 2-arm, Multi-center']}, 'descriptionModule': {'briefSummary': 'Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. This study will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.', 'detailedDescription': 'Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. However, the nephrotoxicity of cisplatin is always a concern therefore cisplatin was substituted with oxaliplatin in current study. S-1 monotherapy has shown promising anti-tumor activity against PDAC with a manageable safety profile which provided the opportunity of combination with other agents. In this study, we will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A.Cytology or histology confirmed pancreatic adenocarcinoma with evidence of distant metastasis.Mixed component of other cell type (eg, adenosquamous, adenocarcinoma with neuroendocrine differentiation) is eligible but should notify PI before registration.\n* B.No history of prior chemotherapy for pancreatic cancer, except adjuvant chemotherapy that completed at least 6 months before documentation of recurrence by imaging study.\n* C.Patients with prior radiotherapy are eligible if there are other measurable target lesions that is not irradiated.\n* D.At least one measurable lesion according to RECIST version 1.1\n* E.Ability to understand and willingness to sign a written informed consent document.\n* F.ECOG performance status 0-1\n* G.Age of 20 years or above\n* H.Adequate organ function as defined by the following criteria:\n\nabsolute neutrophil count (ANC) ≥ 1,500/mm3 hemoglobin level ≥ 9 g/dL platelet count ≥ 100,000/mm3 total bilirubin ≤ 2 ULN or ≤5 ULN if caused by biliary obstruction and achieving adequate drainage judged by investigator aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5.0×ULN in the presence of liver metastases creatinine clearance rate (CCr) ≥ 50 mL/min (24-hour urine collection or calculated by Cockroft-Gault formula; male: \\[(140 - age) × weight (kg)\\]/\\[72 × serum creatinine(mg/dL)\\];female=male x 0.85\n\n-I.Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.\n\nExclusion Criteria:\n\n* A. Other malignancy within the past 5 years except for adequately treated localized cancer or carcinoma in situ;All patients with other malignancy within the past 5 years should notify PI before registration.\n* B.Active or uncontrolled infection;\n* C.Significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications at physician discretion\n* D.Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.\n* E.History of active autoimmune disease within 3 years or use of steroid more than prednisolone 10mg/day.'}, 'identificationModule': {'nctId': 'NCT05026905', 'briefTitle': 'A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Health Research Institutes, Taiwan'}, 'officialTitle': 'A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'T5221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'GASL arm', 'description': "eligible patients will receive gemcitabine 800 mg/m2 on day 1, nab-paclitaxel 125 mg/m2 on day 1, S-1 orally 60-100 mg/day \\[depending on patient's baseline body surface area (BSA)\\] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:\n\n* BSA \\< 1.25 m2: 60 mg/day\n* 1.25 m2 ≤ BSA \\< 1.5 m2: 80 mg/day\n* BSA ≥ 1.5 m2: 100 mg/day", 'interventionNames': ['Drug: Gemcitabine 1000 mg', 'Drug: Nab paclitaxel', 'Drug: S1', 'Drug: leucovorin']}, {'type': 'OTHER', 'label': 'GAP arm', 'description': 'eligible patients will receive gemcitabine 800 mg/m2, nab-paclitaxel 125 mg/m2 and oxaliplatin 75mg/m2 on day 1 in a 2-week cycle.', 'interventionNames': ['Drug: Gemcitabine 1000 mg', 'Drug: Nab paclitaxel', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'Gemcitabine 1000 mg', 'type': 'DRUG', 'otherNames': ['Gemcitabine'], 'description': 'Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days.', 'armGroupLabels': ['GAP arm', 'GASL arm']}, {'name': 'Nab paclitaxel', 'type': 'DRUG', 'otherNames': ['nab-paclitaxel'], 'description': 'Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine', 'armGroupLabels': ['GAP arm', 'GASL arm']}, {'name': 'S1', 'type': 'DRUG', 'otherNames': ['S-1'], 'description': 'S-1 orally 60-100 mg/day day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:\n\n* BSA \\< 1.25 m2: 60 mg/day\n* 1.25 m2 ≤ BSA \\< 1.5 m2: 80 mg/day\n* BSA ≥ 1.5 m2: 100 mg/day', 'armGroupLabels': ['GASL arm']}, {'name': 'leucovorin', 'type': 'DRUG', 'otherNames': ['Calcium Folinate tablet'], 'description': 'leucovorin 30mg BID day 1 to 7 on in a 2-week cycle', 'armGroupLabels': ['GASL arm']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days', 'armGroupLabels': ['GAP arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '800', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '400', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '600', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Li-Tzong Chen, MD, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'National Health Research Institutes, Taiwan'}, {'name': 'Yung-Yeh Su, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Health Research Institutes, Taiwan'}, {'name': 'Shang-Hung Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Health Research Institutes, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Medical University Hospital', 'class': 'OTHER'}, {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}