Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT05180734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-15
First Post:
2021-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 878}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DFS in the PD-L1-positive population evaluated by the BICR', 'timeFrame': '5 years', 'description': 'To evaluate the disease-free survival (DFS) by the blind independent central review (BICR) for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in PD-L1-positive patients with gastric or GEJ adenocarcinoma after radical gastrectomy.'}], 'secondaryOutcomes': [{'measure': 'OS in the PD-L1-positive population', 'timeFrame': '5 years', 'description': 'To evaluate the OS for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in PD-L1-positive patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.'}, {'measure': 'DFS in the PD-L1-positive population evaluated by the investigator', 'timeFrame': '5 years', 'description': 'To evaluate the disease-free survival (DFS) by the investigator for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in PD-L1-positive patients with gastric or GEJ adenocarcinoma after radical gastrectomy.'}, {'measure': 'DFS in the ITT population evaluated by the BICR and investigator, respectively', 'timeFrame': '5 years', 'description': 'To evaluate the disease-free survival (DFS) by the blind independent central review (BICR) and investigator,respectively, for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the ITT population.'}, {'measure': 'OS in the ITT population', 'timeFrame': '5 years', 'description': 'To evaluate the OS for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the ITT population.'}, {'measure': 'DFS rate at 3 years in the PD-L1-positive population and the ITT population evaluated by the BICR and investigator, respectively', 'timeFrame': '3 years', 'description': 'To evaluate the disease-free survival (DFS) rate at 3 years by the BICR and investigator, respevtively, for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.'}, {'measure': 'DFS rate at 5 years in the PD-L1-positive population and the ITT population evaluated by the BICR and investigator, respectively', 'timeFrame': '5 years', 'description': 'To evaluate the disease-free survival (DFS) rate at 5 years by the BICR and investigator, respevtively, for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.'}, {'measure': 'OS rate at 3 years in the PD-L1-positive population and the ITT population', 'timeFrame': '3 years', 'description': 'To evaluate the OS rate at 3 years for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.'}, {'measure': 'OS rate at 5 years in the PD-L1-positive population and the ITT population', 'timeFrame': '5 years', 'description': 'To evaluate the OS rate at 5 years for toripalimab combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in the PD-L1-positive population and the ITT population.'}, {'measure': 'Immunogenicity of toripalimab', 'timeFrame': 'Up to the 90 days from last dose of toripalimab', 'description': 'To evaluate the incidence and titer of anti-drug antibody (ADA) of toripalimab, and further analyze ADA-positive samples for the presence of Neutralising antibodies (Nab).'}, {'measure': 'Blood trough concentration of toripalimab', 'timeFrame': 'Up to the 90 days from last dose of toripalimab', 'description': 'To evaluate the blood trough concentration of toripalimab'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric or Esophagogastric Junction Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This multicenter, randomized, double-blind phase III study intends to recruit about 878 patients, including PD-L1 positive 660 patients, who have received radical gastrectomy (R0 resection, D2 or more extended lymphadenectomy) with postoperative pathological stage IIB or III (AJCC Cancer Staging Manual, 8th Edition) gastric or EGJ adenocarcinoma to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.', 'detailedDescription': '"This is a multicenter, randomized, double-blind phase III study, plans to recruit 878 patients who received radical gastrectomy (R0, D2 or higher lymphadenectomy) with postoperative pathological stage II (T4aN0M0) or III (the 8th Edition American Joint Committee on Cancer \\[AJCC\\] Cancer Staging Manual) gastric adenocarcinoma and gastroesophageal junction adenocarcinoma, and the study intends to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.\n\nPatients meeting the inclusion criteria will be 1:1 randomized into JS001-chemotherapy group and placebo-chemotherapy group. The random stratification factors include adjuvant chemotherapeutic regimens (XELOX versus SOX) and tumor anatomical sites (gastric adenocarcinoma versus gastroesophageal junction adenocarcinoma).\n\nThe study treatment will be initiated 4-6 weeks after surgery, and the investigator will select XELOX (Oxaliplatin + capecitabine) or SOX (Oxaliplatin + S-1, tegafur, gimeracil and oteracil potassium) as the adjuvant chemotherapeutic regimen given as 3-week cycles for up to 8 cycles based on each patient\'s condition; JS001/placebo will be given for up to 17 cycles after surgery, until intolerable toxicity, disease recurrence, patient\'s withdrawal of consent, investigator\'s judgment that the patient needs to be withdrawn from the study treatment, or death, whichever comes first.\n\nSafety evaluation, including vital signs, ECOG score, physical examination and laboratory examinations, will be performed on a regular basis during the treatment.\n\nThis study will end after the main analysis node of DFS and unblinding for analysis are achieved, or 5 years after enrollment of the last patient, whichever comes first. The Sponsor is entitled to terminate the study at any time due to specific reasons (e. g, major safety issues, force majeure, etc.).\n\nRadiological follow-up: tumor response evaluation will be performed once every 12 weeks ±7 days within the first 5 years after randomization, and once per year subsequently, until disease recurrence or death. When symptoms or signs of suspected recurrence/metastasis occur, the radiological evaluation can be performed at any time. Disease recurrence is defined as local recurrence or distant metastases with clear radiological evidence (CT or MRI).\n\nSurvival follow-up: it will be performed once every 12 weeks after disease recurrence, until patient\'s withdrawal of informed consent, loss to follow-up or death, whichever comes first.\n\nSafety follow-up: adverse events will be closely followed up and recorded, until 60 days after the last dose of treatment or the end of study follow-up (death, loss to follow-up, withdrawal of consent form and the end of study), whichever comes first.\n\n"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n1. Age 18-75 years.\n2. No residual tumor (R0) after D2 or greater lymphadenectomy through laparotomy.\n3. According to the definition of the 8th edition of the AJCC Cancer Staging Manual, patients with gastric adenocarcinoma confirmed by histopathology, pathological stage II (T4aN0M0) and stage III, including gastroesophageal junction adenocarcinoma (GEJ) patients.\n4. Patients need to provide sufficient formalin-fixed paraffin-embedded (FFPE) neoplasm tissue specimens or sections that are confirmed to be PD-L1 positive (CPS ≥ 1) by lab test at the central laboratory.\n5. ECOG performance status 0-1.\n6. No metastasis or recurrence as radiologically confirmed.\n7. Patients must have adequate organ function as assessed in the laboratory tests.\n8. Patients must provide informed consent for this study, and sign the written informed consent form voluntarily before the initiation of the study, and are willing and able to comply with the scheduled visits, treatment plan, laboratory examinations and other study procedures in the study.\n9. Female patients of childbearing age must take a serum pregnancy test within 7 days before randomization with negative results, and agree to adopt reliable and effective contraceptive methods during the study.\n\nEXCLUSION CRITERIA\n\n1. Previous use of non-surgical therapy (e.g., radiotherapy, chemotherapy, hormone therapy) for gastric adenocarcinoma.\n2. Having liver, peritoneal or other distant metastasis.\n3. Having malignant tumors other than gastric adenocarcinoma within 5 years before randomization.\n4. Pevious treatment targeting PD-1 receptor or its ligand PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) receptor;\n5. Previous history of serious allergy to monoclonal antibody or other biological preparations.'}, 'identificationModule': {'nctId': 'NCT05180734', 'briefTitle': 'PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Junshi Bioscience Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection Combined With Postoperative Adjuvant Chemotherapy Versus Placebo Combined With Postoperative Adjuvant Chemotherapy in Patients With Gastric or Esophagogastric Junction Adenocarcinoma After Radical Gastrectomy', 'orgStudyIdInfo': {'id': 'JS001-045-III-GC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JS001 240mg, Q3W with XELOX regimen or SOX regimen', 'description': 'JS001 240mg, will be intravenously administered once every 3 weeks, until 17 cycles XELOX regimen (oxaliplatin + capecitabine) or SOX regimen (oxaliplatin + S-1), given in one therapeutic cycle of 3 weeks for up to 8 cycles XELOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; capecitabine, 1000mg/m2, orally, twice per day, from day 1 to day 14, Q3W.\n\nSOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; S-1 Capsules, 40-60mg, orally, twice per day, from day 1 to day 14, Q3W.', 'interventionNames': ['Biological: JS001/Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo combine with chemotherapy', 'description': 'XELOX regimen (oxaliplatin + capecitabine) or SOX regimen (oxaliplatin + S-1), given in one therapeutic cycle of 3 weeks for up to 8 cycles XELOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; capecitabine, 1000mg/m2, orally, twice per day, from day 1 to day 14, Q3W.\n\nSOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; S-1 Capsules, 40-60mg, orally, twice per day, from day 1 to day 14, Q3W.', 'interventionNames': ['Biological: JS001/placebo combine with Postoperative Adjuvant Chemotherapy']}], 'interventions': [{'name': 'JS001/Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['Postoperative Adjuvant Chemotherapy'], 'description': 'JS001/placebo combine with Postoperative Adjuvant Chemotherapy', 'armGroupLabels': ['JS001 240mg, Q3W with XELOX regimen or SOX regimen']}, {'name': 'JS001/placebo combine with Postoperative Adjuvant Chemotherapy', 'type': 'BIOLOGICAL', 'otherNames': ['Postoperative Adjuvant Chemotherapy'], 'description': 'JS001/placebo combine with Postoperative Adjuvant Chemotherapy', 'armGroupLabels': ['Placebo combine with chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233300', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'city': 'Chizhou', 'state': 'Anhui', 'country': 'China', 'facility': "The Peple's Hospital of Chizhou", 'geoPoint': {'lat': 30.66134, 'lon': 117.47783}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510515', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer hospital', 'geoPoint': {'lat': 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'facility': 'Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '441021', 'city': 'Xiangyang', 'state': 'Hubei', 'country': 'China', 'facility': 'Xiangyang Central Hospital', 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}, {'zip': '443008', 'city': 'Yichang', 'state': 'Hubei', 'country': 'China', 'facility': "Yichang Central People's Hospital", 'geoPoint': {'lat': 30.71444, 'lon': 111.28472}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410031', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Cancer Hopital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '213004', 'city': 'Changzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "The First People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'zip': '210000', 'city': 'Nanjing', 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Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '810000', 'city': 'Xining', 'state': 'Qinghai', 'country': 'China', 'facility': 'Qinghai University Affiliated Hosptial', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Cancer Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '276002', 'city': 'Linyi', 'state': 'Shandong', 'country': 'China', 'facility': 'Linyi Cancer Hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '266003', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '266042', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'Qingdao central medical group', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '250012', 'city': 'Jinan', 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'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '710000', 'city': 'Xian', 'state': 'Shanxi', 'country': 'China', 'facility': 'Tangdu hospital, Air force Military Medical University'}, {'zip': '710000', 'city': 'Xian', 'state': 'Shanxi', 'country': 'China', 'facility': 'Xijing hospital, Air force Military Medical University'}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'SiChuan Cancer Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '629000', 'city': 'Suining', 'state': 'Sichuan', 'country': 'China', 'facility': 'Suining Central Hospital', 'geoPoint': {'lat': 30.50802, 'lon': 105.57332}}, {'zip': '830000', 'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Cancer Hospital affiliated to Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The first affiliated hospital of Zhejiang medical university', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '314001', 'city': 'Jiaxing', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Hospital of Jiaxing', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}, {'zip': '325024', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Junshi Bioscience Co., Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}