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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HX008 plus Irinotecan | Experimental | Participants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W. |
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| Placebo plus Irinotecan | Placebo Comparator | Participants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan Hydrochloride Injection | Drug | 160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in All Participants | 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. | Up to approximately 36 months |
| Overall Survival (OS) in Participants With PD-L1 CPS≥1 | 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. | Up to approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 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. | Up to approximately 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Huang, MD | Contact | 010-87788113 | huangjingwg@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Recruiting | Hefei | Anhui | 230000 | China |
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| HX008 | Drug | 200 mg administered as IV infusion on Day 1 of each 21-day cycle. |
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| Placebo | Drug | Administered as IV infusion on Day 1 of each 21-day cycle. |
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| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
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. |
| Up to approximately 36 months |
| Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 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. | Up to approximately 36 months |
| Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | 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. | Up to approximately 36 months |
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | 230001 | China |
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| The Second Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230601 | China |
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| Beijing ChaoYang Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| Cancer Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
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| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| Peking University Internationale Hospital | Recruiting | Beijing | Beijing Municipality | 102206 | China |
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| Chongqing University Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| Fujian Cancer Hospital | Recruiting | Xiamen | Fujian | 350000 | China |
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| Gansu Wuwei Tumor Hospital | Recruiting | Wuwei | Gansu | 350000 | China |
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| Affiliated Cancer Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510095 | China |
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| Zhongshan People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 528403 | China |
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| Peking University Shenzhen Hospital | Recruiting | Shenzhen | Guangdong | 518035 | China |
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| Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center | Recruiting | Shenzhen | Guangdong | 518117 | China |
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| Guangxi Medical University Cancer Hospital | Recruiting | Naning | Guangxi | 530021 | China |
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| The First Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangzhou | 510080 | China |
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| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050051 | China |
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| Affiliated Hospital of Hebei University | Recruiting | Shijiazhuang | Hebei | 071000 | China |
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| The affiliated Cancer Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| The First Affiliated Hospital of Henan Science&Technology University | Recruiting | Zhengzhou | Henan | 471000 | China |
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| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 540003 | China |
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| The Second Xiangya Hospital of Cancer South University | Recruiting | Changsha | Hunan | 410000 | China |
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| Xiangya Hospital, Central South University | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410200 | China |
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| The Affiliated People's Hospital of Inner Mongolia Medical University | Recruiting | Hohhot | Inner Mongolia | 010000 | China |
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| Changzhou Cancer Hospital | Recruiting | Changzhou | Jiangsu | 213000 | China |
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| Jiangsu Provincial Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| Zhongda Hospital Southeast Universtiy | Not yet recruiting | Nanjing | Jiangsu | 210009 | China |
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| Nantong Tumor Hospital | Recruiting | Nantong | Jiangsu | 226006 | China |
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| The Second Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| Xuzhou Central Hospital | Recruiting | Xuzhou | Jiangsu | 221009 | China |
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| Yangzhou FIrst People's Hospital | Recruiting | Yangzhou | Jiangsu | 225000 | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
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| Jiangxi Cancer Hospital | Recruiting | Nanchang | Jiangxi | 330029 | China |
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| Jilin Cancer Hospital | Recruiting | Changchun | Jilin | 130000 | China |
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| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130000 | China |
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| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
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| Liaoning Cancer Hospital | Recruiting | Shenyang | Liaoning | 110042 | China |
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| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | 750001 | China |
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| Shandong Provincial Hospital | Recruiting | Jinan | Shandong | 250000 | China |
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| Shandong Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| The Affiliated Hospital of Qingdao University | Recruiting | Qingdao | Shandong | 266000 | China |
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| Yantai Yuhuangding Hospital | Not yet recruiting | Yantai | Shandong | 264000 | China |
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| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Shanghai Sixth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200233 | China |
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| Shanxi Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030013 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi’an | Shanxi | 710061 | China |
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| Sichuan Cancer Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
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| Hubei Cancer Hospital | Recruiting | Hubei | Wuhan | 430000 | China |
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| The First Affiliated Hospital of Xinjiang Medical University | Recruiting | Ürümqi | Xinjiang | 830000 | China |
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| Xinjiang Medical University Cancer Hospital | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | 650100 | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
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| Sir Run Run Shaw Hospital, Medical School of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310016 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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