Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 5:44 PM
Study NCT ID:
NCT07464756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723862', 'term': 'SHR-1701'}, {'id': 'C553458', 'term': 'apatinib'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response (pCR)', 'timeFrame': 'Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment'}], 'secondaryOutcomes': [{'measure': 'Tumor Regression Grade (TRG)', 'timeFrame': 'Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment'}, {'measure': 'ypN staging', 'timeFrame': 'Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment'}, {'measure': 'R0 resection rate', 'timeFrame': 'Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment'}, {'measure': 'Event free survival (EFS)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'Overall survival(OS)', 'timeFrame': 'Up to approximately 4 years'}, {'measure': 'AEs', 'timeFrame': 'Up to approximately 3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.', 'detailedDescription': 'This study enroll patients with resectable, locally advanced (cT3-4aN+M0) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received anticancer therapy. Eligible subjects will be randomized in a 1:1 ratio to one of the two intervention arms. Arm 1：SHR-1701, apatinib, and SOX. Arm2: SHR-1701 and SOX. Arm 1 incorporates a safety run-in phase, during which the first 6 subjects enrolled in this cohort will undergo safety observation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients voluntarily participate in this study and provide signed informed consent;\n2. Age ≥18 years old;\n3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);\n4. Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable\n5. No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);\n6. Plan to proceed to surgery after completion of neoadjuvant therapy;\n7. Able to swallow tablets normally;\n8. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n9. Estimated life expectancy ≥12 months;\n10. Has adequate organ function.\n11. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and must agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 6 months after chemotherapy (whichever is longer). Male subjects with partners of childbearing potential must be surgically sterile or agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 3 months after chemotherapy (whichever is longer), and must not donate sperm during the study.\n\nExclusion Criteria:\n\n1. Known HER2 positive\n2. Need transthoracic surgical approach Based on the investigator's judgment\n3. Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4 Presence of unresectable factors, including unresectability due to tumor-related reasons, contraindications to surgery, or refusal of surgery;\n\n5\\. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)； 7. Known hypersensitivity to any of the study drugs or excipients; 8. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 9. Congenital or acquired immune deficiency (e.g. HIV infected)"}, 'identificationModule': {'nctId': 'NCT07464756', 'briefTitle': 'SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'A Prospective Exploratory Study of SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma', 'orgStudyIdInfo': {'id': 'MA-GC-II-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1701, apatinib, and SOX', 'interventionNames': ['Drug: SHR-1701', 'Drug: apatinib', 'Drug: S-1 & Oxaliplatin']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-1701 and SOX', 'interventionNames': ['Drug: SHR-1701', 'Drug: S-1 & Oxaliplatin']}], 'interventions': [{'name': 'SHR-1701', 'type': 'DRUG', 'description': 'SHR-1701, 1800mg, Q3w', 'armGroupLabels': ['SHR-1701 and SOX', 'SHR-1701, apatinib, and SOX']}, {'name': 'apatinib', 'type': 'DRUG', 'description': 'apatinib 250mg，Q3W', 'armGroupLabels': ['SHR-1701, apatinib, and SOX']}, {'name': 'S-1 & Oxaliplatin', 'type': 'DRUG', 'description': 'S-1, Oxaliplatin, Q3w', 'armGroupLabels': ['SHR-1701 and SOX', 'SHR-1701, apatinib, and SOX']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}