Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT04140318
Status:
UNKNOWN
Last Update Posted:
2022-03-11
First Post:
2019-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000632826', 'term': 'sintilimab'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2019-10-24', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to two years'}], 'secondaryOutcomes': [{'measure': 'DCR', 'timeFrame': 'up to three years', 'description': 'disease control rate'}, {'measure': 'DOR', 'timeFrame': 'up to three years', 'description': 'duration of response'}, {'measure': 'AE', 'timeFrame': 'from first dose to 90days of last dose', 'description': 'treatment related adverse event'}, {'measure': 'PFS', 'timeFrame': 'up to three years', 'description': 'progression free survival'}, {'measure': 'OS', 'timeFrame': 'up to three years', 'description': 'overall survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['second line', 'PD-1', 'nab-paclitaxel'], 'conditions': ['Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathological confirmed advanced gastric and gastro-esophageal junction adenocarcinoma;\n* progression after first-line treatment of fluoropyrimidine and platinum, allow patients progressed on/within 6 months of neoadjuvant/adjuvant treatment; allow local radiotherapy after 21days later;\n* 18-75 years old;\n* ECOG: 0 or 1;\n* has adequate organ function\n* writen ICF;\n\nExclusion Criteria:\n\n* previous treated with taxanes (including paclitaxel, nab-PTX, lipo-PTX, and docetaxel etc..);\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody;\n* has known active central nervous system metastatases;\n* has received a live vaccine within 4 weeks prior to the first dose of study treatment with any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.\n* clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \\> 2), orventricular arrhythmia which need medical intervention.\n* hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg. coagulation abnormalities (INR \\> 1.5 or APTT \\> 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.'}, 'identificationModule': {'nctId': 'NCT04140318', 'briefTitle': 'Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Efficacy and Safety of Sintilimab and Nab-paclitaxel in Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma Patients With Progression After Fluoropyrimidine or Platinum, a Multi-center, Phase II, Single Arm Trial', 'orgStudyIdInfo': {'id': 'NCC2070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'description': 'combination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w', 'interventionNames': ['Drug: sintilimab', 'Drug: nab-paclitaxel']}], 'interventions': [{'name': 'sintilimab', 'type': 'DRUG', 'description': 'Sintilimab 200mg, iv, 30-60min, q3w;', 'armGroupLabels': ['treatment']}, {'name': 'nab-paclitaxel', 'type': 'DRUG', 'description': 'Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ai ping Zhou', 'role': 'CONTACT', 'email': 'zhouap1825@126.com', 'phone': '8610-87788145'}], 'facility': 'Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Aiping Zhou, MD', 'role': 'CONTACT', 'email': 'zhouap1825@126.com', 'phone': '8687788145'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The baseline characteristics of patients could be shared to othter researchers per request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, {'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Aiping Zhou', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}