Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT04486651
Status:
UNKNOWN
Last Update Posted:
2021-01-28
First Post:
2020-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2020-07-22', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS) in All Participants', 'timeFrame': 'Up to approximately 36 months', 'description': 'OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm.'}, {'measure': 'Overall Survival (OS) in Participants With PD-L1 CPS≥1', 'timeFrame': 'Up to approximately 36 months', 'description': 'OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS is reported here for all participants in the experimental arm and placebo comparator arm with PD-L1 CPS≥1.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 36 months', 'description': 'PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.'}, {'measure': 'Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 36 months', 'description': 'ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.'}, {'measure': 'Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 36 months', 'description': 'DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.'}, {'measure': 'Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Up to approximately 36 months', 'description': 'DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stomach Cancer']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blinded, multicenter study to evaluate the efficacy and safety of HX008 injection combined with irinotecan versus placebo combined with irinotecan as second-line therapy in patients with adcanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have had tumor progression after first-line treatment with platinum and/or fluropyrimidine therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understood and signed an informed consent form.\n* Age ≥ 18 and ≤ 75 years old, male or female.\n* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ).\n* Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy.\n* Willing to provide tissue for PD-L1 biomarker analysis.\n* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.\n* Life expectancy ≥ 3 months.\n* Has adequate organ function.\n* Female participants of childbearing potential should have a negative pregnancy within 72 hours before the randomization. Male and female participants should agree to use an adequate method of contraception during the experiment and 1 year after the last administration of the test drugs.\n\nExclusion Criteria:\n\n* Has squamous cell or undifferentiated gastric cancer.\n* Diagnosed additional maliganancy within 3 years prior to randomization with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.\n* Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.\n* Has had prior chemotherapy,radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.\n* Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Has uncontrolled ascites, pleural effusion, or pericardial effusion.\n* Has active autoimmune disease that has required systemic treatment in past 2 years.\n* Has received a major surgery within 4 weeks prior to randomization.\n* Has received system treatment with corticosteroids (dose \\>10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.\n* Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation.\n* Has a history of non-infectious pneumonitis that required steriods or has current pneumonitis.\n* Has any serious and/or uncontrolled disease.\n* Has active viral infection.\n* Has received a live vaccine within 30 days prior to the first dose of trial treatment.\n* Has participated in other anticancer drug clinical trials within 4 weeks.\n* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.'}, 'identificationModule': {'nctId': 'NCT04486651', 'briefTitle': 'HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taizhou Hanzhong biomedical co. LTD'}, 'officialTitle': 'A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HX008 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'HX008-III-GC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HX008 plus Irinotecan', 'description': 'Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.', 'interventionNames': ['Drug: Irinotecan Hydrochloride Injection', 'Drug: HX008']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus Irinotecan', 'description': 'Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.', 'interventionNames': ['Drug: Irinotecan Hydrochloride Injection', 'Drug: Placebo']}], 'interventions': [{'name': 'Irinotecan Hydrochloride Injection', 'type': 'DRUG', 'description': '160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.', 'armGroupLabels': ['HX008 plus Irinotecan', 'Placebo plus Irinotecan']}, {'name': 'HX008', 'type': 'DRUG', 'description': '200 mg administered as IV infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['HX008 plus Irinotecan']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered as IV infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Placebo plus Irinotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yifu He', 'role': 'CONTACT'}], 'facility': 'Anhui Provincial Cancer Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yueyin Pan', 'role': 'CONTACT'}], 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230601', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhendong Chen', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guangyu An', 'role': 'CONTACT'}], 'facility': 'Beijing ChaoYang Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Huang, MD', 'role': 'CONTACT', 'email': 'huangjingwg@163.com'}], 'facility': 'Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Zhao', 'role': 'CONTACT'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bangwei Cao', 'role': 'CONTACT'}], 'facility': 'Beijing Friendship Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Baoshan Cao', 'role': 'CONTACT'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '102206', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Liang', 'role': 'CONTACT'}], 'facility': 'Peking University Internationale Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiqing Chen', 'role': 'CONTACT'}], 'facility': 'Chongqing University Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '350000', 'city': 'Xiamen', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rongbo Lin', 'role': 'CONTACT'}], 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '350000', 'city': 'Wuwei', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rongbo Lin', 'role': 'CONTACT'}], 'facility': 'Gansu Wuwei Tumor Hospital', 'geoPoint': {'lat': 37.92672, 'lon': 102.63202}}, {'zip': '510095', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuan Jin', 'role': 'CONTACT'}], 'facility': 'Affiliated Cancer Hospital of 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'contacts': [{'name': 'Zhihui Liu', 'role': 'CONTACT'}], 'facility': 'Guangxi Medical University Cancer Hospital', 'geoPoint': {'lat': 22.89905, 'lon': 107.65003}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sheng Ye', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '050011', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shengmian Li', 'role': 'CONTACT'}], 'facility': 'The Fourth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '050051', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Na Li', 'role': 'CONTACT'}], 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': 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University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '471000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinshuai Wang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Henan Science&Technology University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '540003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shundong Cang', 'role': 'CONTACT'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xianling Liu', 'role': 'CONTACT'}], 'facility': 'The Second Xiangya Hospital of Cancer South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 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First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110042', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingdong Zhang', 'role': 'CONTACT'}], 'facility': 'Liaoning Cancer Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '750001', 'city': 'Yinchuan', 'state': 'Ningxia', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ping Chen', 'role': 'CONTACT'}], 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}, {'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weibo Wang', 'role': 'CONTACT'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bo 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