Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-06-06 @ 11:01 PM
Study NCT ID:
NCT03990103
Status:
UNKNOWN
Last Update Posted:
2019-06-19
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S1+ Paclitaxel (IV&IP) + Bevacizumab (IP) Versus S1+Oxaliplatin as First-line Treatment in Gastric Cancer With Malignant Ascites
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-17', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-06-17', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ascites response rate at 6 weeks', 'timeFrame': '6 weeks', 'description': 'response of ascites at 6 weeks'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': '12 months', 'description': 'Progression-free survival,From 1st drug administration to the date of first progression or date of death (whichever occurs first)'}, {'measure': 'OS', 'timeFrame': '2 years', 'description': 'Overall survival, from enrollment until death from any cause'}, {'measure': 'ORR', 'timeFrame': '12 months', 'description': 'Objective response rate, the proportion of patients with reduction in tumor burden of a predefined amount'}, {'measure': 'TTF', 'timeFrame': '12 months', 'description': 'Time to treatment failure, from 1st drug administration to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death'}, {'measure': 'Puncture free survival', 'timeFrame': '12 months', 'description': 'Puncture free survival time, from the first puncture to secondary puncture'}, {'measure': 'Volume of drainage', 'timeFrame': '12 months', 'description': 'Volume of drainage'}, {'measure': 'Adverse events', 'timeFrame': '12 months', 'description': 'Adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Carcinoma', 'Malignant Ascites', 'Intraperitoneal Chemotherapy', 'Bevacizumab'], 'conditions': ['Metastatic Gastric Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of S1 plus paclitaxel (intravenous injection \\& intraperitoneal injection) plus bevacizumab (intraperitoneal injection) vs. S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites.', 'detailedDescription': 'This is a prospective, open-label, multicenter clinical trial, to compare the efficacy of S1 plus paclitaxel (intravenous injection \\& intraperitoneal injection) plus bevacizumab (intraperitoneal injection) versus S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites. A total of 66 patients who are diagnosed with gastric or gastroesophageal junctional adenocarcinoma will be allocated to receive either S1 orally administration plus paclitaxel intravenous injection \\& intraperitoneal injection plus bevacizumab intraperitoneal injection, or to receive S1 orally administration plus oxaliplatin intravenous injection. The primary end point is ascites response rate at 6 weeks. The secondary end points include the median overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), objective response rate (ORR), puncture free survival, volume of drainage, the quality of life (QoL) and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years ≥ Age≤ 70 years, male or female\n* Pathologically confirmed adenocarcinoma of the gastric or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease; with medium amount of malignant ascites which can be catheterized.\n* Diagnostic criteria for malignant ascites (meet any of the following criteria): ascites cytology positive; or imaging or pathological confirmed peritoneal metastases.\n* No prior anti-tumor treatment to the metastatic disease; an interval of at least 6 months from the last adjuvant chemotherapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status( PS) score 0-1.\n* Normal major organ function, and laboratory tests must meet the following criteria: hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×109/L, platelet count ≥ 100×109/L, total bilirubin (TBil) ≤ 1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 UNL, serum creatinine (Cr) ≤ 1 UNL; creatinine clearance rate (CCr) ≥ 60 ml/min (calculated using the Cockcroft-Gault equation).\n* International Normalized Ratio (INR) ≤ 1.5 and partial prothrombin time (PPT) or activated partial thromboplastin time (APTT) ≤ 1.5 UNL within 7 days before enrollment.\n* Life expectancy of at least 12 weeks\n* Signed informed consent (ICF)\n* For women of child bearing potential, a negative serum or urine pregnancy test result should be obtained with 7 days before enrollment; Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergic to any of the study drugs, study drug classes, or excipients in the formulation.\n* Subject received chemotherapy to the metastatic disease (except adjuvant/neoadjuvant chemotherapy administered 24 weeks before enrollment)\n* Subject with other malignancies, except for non-melanoma skin cancer or in-situ cervical carcinoma under adequate treatment, or other treated malignancies without evidence of recurrent for 5 years.\n* Anti-tumor cytotoxic drug therapy within 14 days prior to enrollment（longer washout time interval might needed depends on drug characteristics）\n* Uncontrolled hypertension which cannot be reduced to normal range by antihypertensive agents \\[Systolic Blood Pressure(SBP) \\>140 mmHg, diastolic blood pressure (DBP) \\> 90 mmHg\\], coronary artery disease \\> grade 1, arrhythmia \\> grade 1 \\[including corrected QT(QTc) interval prolongation: QTc\\>450 ms for male，QTc\\>470 ms for female\\], grade 1 heart failure.\n* Proteinuria ≥ ++，or persistent proteinuria \\> 1.0 g/24 hours\n* Presence of any toxicity ≥ grade 1 according to NCI-CTCAE except for alopecia.\n* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks, cerebral hemorrhage、cerebral infarction), deep vein thrombosis and pulmonary embolism within 12 months before enrollment.\n* Bowel obstruction within 6 weeks before enrollment.\n* Surgical treatment was performed within 6 weeks before enrollment. Subject should recover from any major surgery.\n* Serious uncontrolled systemic illness or medical condition or uncontrolled infections, including but not limited to: uncontrollable ventricular arrhythmias, history of documented myocardial infarction within 3 months, uncontrollable epileptic dementia, unstable spinal compression, superior vena cava syndrome, extensive bilateral interstitial pulmonary disease by high-resolution computed tomography (HRCT), or any neurological or mental abnormalities which affect compliance.\n* Human immunodeficiency virus (HIV) positive\n* Pregnancy or lactation women\n* Cannot be orally administered medication\n* Subject with a tendency for gastrointestinal hemorrhage. Including: Black stool or hematemesis within 2 months; For subjects positive in occult test with unresected primary lesion, if the principle investigator in each center considers with possibility of gastrointestinal hemorrhage, the subject could not be enrolled.\n* Subject with malignant pleural effusion need medical intervention.\n* A history or evidence of hereditary hemorrhagic constitution or coagulation disorder that increases the risk of bleeding\n* Subjects with central nerve system metastases\n* Have been enrolled in other clinical trial with investigational drug treatment within the 4 weeks of start of study treatment\n* For subject with bone metastases, palliative radiotherapy was given 4 weeks before enrollment (radiation field \\>5%).\n* Any other disease or condition that the investigator considers not suitable for participating in this clinical trial.'}, 'identificationModule': {'nctId': 'NCT03990103', 'briefTitle': 'S1+ Paclitaxel (IV&IP) + Bevacizumab (IP) Versus S1+Oxaliplatin as First-line Treatment in Gastric Cancer With Malignant Ascites', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University, China'}, 'officialTitle': 'S1 Plus Paclitaxel (IV&IP) Plus Bevacizumab (IP) Versus S1 Plus Oxaliplatin(IV) as First-line Treatment in Gastric or Gastroesophageal Junctional Adenocarcinoma With Malignant Ascites: An Open-label, Multicenter Phase II Study', 'orgStudyIdInfo': {'id': 'CLOG1704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'S1+Paclitaxel (IV\\&IP)+Bevacizumab (IP)', 'interventionNames': ['Drug: S1', 'Drug: Paclitaxel', 'Drug: Bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'description': 'S1+Oxaliplatin (IV)', 'interventionNames': ['Drug: S1', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'S1', 'type': 'DRUG', 'otherNames': ['Tegafur Gimeracil Oteracil Potassium Capsule'], 'description': '80-120 mg/day, PO, D1-14, every 21 days', 'armGroupLabels': ['Control arm', 'Experimental arm']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Paclitaxel Injection'], 'description': '20 mg/m2/day, IP, D1-3; 50 mg/m2, IV, D1; 70 mg/m2, IV, D8; every 21 days', 'armGroupLabels': ['Experimental arm']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin ®'], 'description': '200 mg, IP, D1, every 21 days', 'armGroupLabels': ['Experimental arm']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'otherNames': ['ELOXATIN®'], 'description': '130 mg/m2, IV, D1, every 21 days', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunpeng Liu, Ph.D', 'role': 'CONTACT'}, {'name': 'Xiujuan Qu, M.D.', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Yunpeng Liu, M.D.', 'role': 'CONTACT', 'email': 'cmu_trial@163.com', 'phone': '86-24-83282312'}, {'name': 'Xiujuan Qu, M.D.', 'role': 'CONTACT', 'email': 'cmuquxiujuan@163.com', 'phone': '86-24-83282312'}], 'overallOfficials': [{'name': 'Yunpeng Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'not yet decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Yunpeng Liu', 'investigatorAffiliation': 'China Medical University, China'}}}}