Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-01-07 @ 11:00 PM
Study NCT ID:
NCT03258034
Status:
UNKNOWN
Last Update Posted:
2017-08-22
First Post:
2017-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-08-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2021-10-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-21', 'studyFirstSubmitDate': '2017-08-20', 'studyFirstSubmitQcDate': '2017-08-21', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3 year OS', 'timeFrame': '3 years', 'description': 'The overall survival time'}], 'secondaryOutcomes': [{'measure': 'radical resection rate', 'timeFrame': '4 months', 'description': 'the radical resection rates'}, {'measure': '3 year DFS', 'timeFrame': '3 years', 'description': 'the diesease free survival time'}, {'measure': '5 year OS', 'timeFrame': '5 years', 'description': 'The overall survival time'}, {'measure': 'adverse events', 'timeFrame': '7months', 'description': 'number and degree of adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Conversion therapy'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The prognosis of Extensive lymph nodes metastatic(ELM) gastric cancer is poor. Chemotherapy occasionally converts it to a resectable cancer. Previous studies showed patients with ELM gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative surgery. The key of conversion therapy of ELMGC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. On the basis of our previous Ahead-G325 study, The purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the conversion therapys of ELM gastric cancer.', 'detailedDescription': 'The investigators will apply SPA regimen for coversional therapy to abtain high response rate. Paclitaxel：150 mg/m2 i.v.3h , given on the first day. Apatinib, oral ,initial dose :425mg, QD, after meal ( try to take the medicine at the same time of the day ). Dose adjustment: Down-regulate the dosage to 250 mg per day at the first time. If the patient totally recovers from the toxic reaction after the regulation, we could up-regulate the dosage back to the former level. If the downregulation occurs again according to the protocol , then the up-regulation will be forbidden.\n\nS-1 dosage: According to the body surface area, the initial dosage of S-1 is decided by the following criteria. Take the medicine twice daily (after breakfast and supper) for 2 weeks, then suspend for 1 week. Preventive medication: To prevent serious allergic reaction of Paclitaxel, preventive medication should be given in advance. We usually give dexamethasone 20mg orally 12 and 6 hours before the Paclitaxel, and diphenhydramine (or something analogous) 50 mg, cimetidine 300mg (or ranitidine 50mg) I.V. 30-60 minutes before the Paclitaxel. Repeat the therapeutic schedule every 3 weeks. 3-4 cycles of neoadjuvant chemotherapy before surgery, stop Apatinib in the last cycle.4 cycles of adjuvant chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ELM gastric cancer as proven histologically under following condition: unable radical excision due to the abdominal aorta a2-b1 or extensive lymph nodes metastatic,\n* Definitely diagnosed as above stage of gastric cancer before operation via CT of MRI, ultrasonic endoscopy, PET-CT, or through the laparoscopic exploration if necessary\n* Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)\n* Negative HER-2 state\n* ECOG(Eastern Cooperative Oncology Group): 0\\~2\n* Age: 18\\~70 years old- survival time \\> 3monts\n* Normal hemodynamic indices before the recruitment(including blood cell count and liver/kidney function ). For example: WBC\\>4.0\\*109/ L, NE\\>1.5\\*109/L, PLT\\>100\\*109/L, BIL\\<1.5 times of upper limit of normal reference value, ALT and AST\\<2.5 times of upper limit of normal reference value, and CRE\\<1.2mg/dl\n* Good cardiac function before the recruitment, no seizure of myocardial infarction in past half years, and controllable hypertension and other coronary heart disease\n* Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver)\n* Not participating in other clinical trials before and during the treatment\n* Signed the Informed Consent Form\n* No peritoneal metastatic and CY0 in 28 days by laparoscopic exploration\n* Non-gastric stump cancer\n* No esophagus infiltrating or infiltrating less than 3cm\n\nExclusion Criteria:\n\n* Distal metastasis to Mediastinal lymph node,liver ,peritoneal,pleural effusion ,ascites,above 16a2-b1 and others\n* Severe mental illness\n* Her-2 positive, desire for hercptin treatment\n* Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment\n* Allergy to the drugs in this protocol\n* Pregnant and lactating women\n* Women at childbearing age and of pregnancy desire during the study'}, 'identificationModule': {'nctId': 'NCT03258034', 'briefTitle': 'A Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhejiang Chinese Medical University'}, 'officialTitle': 'Phase II Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer', 'orgStudyIdInfo': {'id': 'Ahead-G328'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conversion treatment', 'description': 'after 3-4 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent.', 'interventionNames': ['Drug: SPA']}], 'interventions': [{'name': 'SPA', 'type': 'DRUG', 'description': 'S1/Paclitaxel chemotherapy plus Apatinib S1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:425mg once daily', 'armGroupLabels': ['Conversion treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hanzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The first affiliated hospital of zhejiang chinese medical university'}], 'overallOfficials': [{'name': 'Xiangdong Cheng, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital of Zhejiang Chinese Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhejiang Chinese Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}