Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:40 AM
Study NCT ID:
NCT07384234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-03
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723862', 'term': 'SHR-1701'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'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': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-26', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-01-26', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year overall survival rate', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Conversion surgery rate', 'timeFrame': 'Up to 4 weeks after completion of surgery'}, {'measure': 'R0 resection rate', 'timeFrame': 'Up to 4 weeks after completion of surgery'}, {'measure': 'Pathological complete response(pCR)', 'timeFrame': 'Up to 4 weeks after completion of surgery'}, {'measure': 'Tumor regression grade', 'timeFrame': 'Up to 4 weeks after completion of surgery'}, {'measure': 'Event free survival (EFS)', 'timeFrame': 'Up to 2 years'}, {'measure': 'DFS', 'timeFrame': 'Up to 2 years', 'description': 'Disease-free survival (DFS)'}, {'measure': 'Overall survival(OS)', 'timeFrame': 'Up to 3 years'}, {'measure': 'AEs', 'timeFrame': 'Up to approximately 18 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion).\n3. Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian metastasis is permitted), and without gastric outlet obstruction or intestinal obstruction.\n4. No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n6. Normal function of major organs.\n\nExclusion Criteria:\n\n1. Known HER2-positive.\n2. Previous history of gastric cancer surgery.\n3. Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.\n4. Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).\n5. Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease.\n6. Significant cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction.'}, 'identificationModule': {'nctId': 'NCT07384234', 'briefTitle': 'SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: A Randomized, Two-Cohort Study', 'orgStudyIdInfo': {'id': 'MA-GC-II-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1', 'interventionNames': ['Drug: SHR-1701', 'Drug: S-1', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-1701 and CAPOX', 'interventionNames': ['Drug: SHR-1701', 'Drug: Capecitabine', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'SHR-1701', 'type': 'DRUG', 'description': 'SHR-1701, 1800mg, Q3w', 'armGroupLabels': ['SHR-1701 and CAPOX', 'SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine, Q3W', 'armGroupLabels': ['SHR-1701 and CAPOX']}, {'name': 'S-1', 'type': 'DRUG', 'description': 'S-1, Q3W', 'armGroupLabels': ['SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel,Q3W', 'armGroupLabels': ['SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Oxaliplatin, Q3W', 'armGroupLabels': ['SHR-1701 and CAPOX']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Yanan Zheng', 'role': 'CONTACT', 'email': 'ianzyn@163.com', 'phone': '+8613636404065'}, {'name': 'Yanan Zheng', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin Hospital, Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yanan Zheng', 'role': 'CONTACT', 'email': 'ianzyn@163.com', 'phone': '+8613636404065'}], 'overallOfficials': [{'name': 'Yanan Zheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}