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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04486651
Other study ID # HX008-III-GC-01
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 16, 2020
Est. completion date August 10, 2023

Study information

Verified date January 2021
Source Taizhou Hanzhong biomedical co. LTD
Contact Jing Huang, MD
Phone 010-87788113
Email huangjingwg@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 560
Est. completion date August 10, 2023
Est. primary completion date August 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Understood and signed an informed consent form. - Age = 18 and = 75 years old, male or female. - Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ). - Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing platinum and/or fluoropyrimidine therapy. - Willing to provide tissue for PD-L1 biomarker analysis. - Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score. - Life expectancy = 3 months. - Has adequate organ function. - 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. Exclusion Criteria: - Has squamous cell or undifferentiated gastric cancer. - 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. - 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. - 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. - Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents. - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Has uncontrolled ascites, pleural effusion, or pericardial effusion. - Has active autoimmune disease that has required systemic treatment in past 2 years. - Has received a major surgery within 4 weeks prior to randomization. - 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. - Has incomplete intestinal obstruction, active gastrointestinal hemorrhage and perforation. - Has a history of non-infectious pneumonitis that required steriods or has current pneumonitis. - Has any serious and/or uncontrolled disease. - Has active viral infection. - Has received a live vaccine within 30 days prior to the first dose of trial treatment. - Has participated in other anticancer drug clinical trials within 4 weeks. - According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Irinotecan Hydrochloride Injection
160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
HX008
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
Placebo
Administered as IV infusion on Day 1 of each 21-day cycle.

Locations

Country Name City State
China Beijing ChaoYang Hospital, Capital Medical University Beijing Beijing
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing
China Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing
China Peking Union Medical College Hospital Beijing Beijing
China Peking University Internationale Hospital Beijing Beijing
China Peking University Third Hospital Beijing Beijing
China Jilin Cancer Hospital Changchun Jilin
China The First Hospital of Jilin University Changchun Jilin
China Hunan Cancer Hospital Changsha Hunan
China The Second Xiangya Hospital of Cancer South University Changsha Hunan
China Xiangya Hospital, Central South University Changsha Hunan
China Changzhou Cancer Hospital Changzhou Jiangsu
China Sichuan Cancer Hospital Chengdu Sichuan
China Chongqing University Cancer Hospital Chongqing Chongqing
China Affiliated Cancer Hospital of Guangzhou Medical University Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangzhou
China Zhongshan People's Hospital Guangzhou Guangdong
China Sir Run Run Shaw Hospital, Medical School of Zhejiang University Hangzhou Zhejiang
China The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Zhejiang Provincial People's Hospital Hangzhou Zhejiang
China The affiliated Cancer Hospital of Harbin Medical University Harbin Heilongjiang
China Anhui Provincial Cancer Hospital Hefei Anhui
China Anhui Provincial Hospital Hefei Anhui
China The Second Affiliated Hospital of Anhui Medical University Hefei Anhui
China Hubei Cancer Hospital Hubei Wuhan
China The Affiliated People's Hospital of Inner Mongolia Medical University Huhhot Inner Mongolia
China Shandong Cancer Hospital Jinan Shandong
China Shandong Provincial Hospital Jinan Shandong
China Yunnan Cancer Hospital Kunming Yunnan
China Jiangxi Cancer Hospital Nanchang Jiangxi
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Guangxi Medical University Cancer Hospital Naning Guangxi
China Jiangsu Provincial Hospital Nanjing Jiangsu
China Nanjing Drum Tower Hospital Nanjing Jiangsu
China Zhongda Hospital Southeast Universtiy Nanjing Jiangsu
China Nantong Tumor Hospital Nantong Jiangsu
China The Affiliated Hospital of Qingdao University Qingdao Shandong
China Shanghai General Hospital Shanghai Shanghai
China Shanghai Sixth People's Hospital Shanghai Shanghai
China Liaoning Cancer Hospital Shenyang Liaoning
China The First Hospital of China Medical University Shenyang Liaoning
China Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center Shenzhen Guangdong
China Peking University Shenzhen Hospital Shenzhen Guangdong
China Affiliated Hospital of Hebei University Shijiazhuang Hebei
China The First Hospital of Hebei Medical University Shijiazhuang Hebei
China The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
China The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
China Shanxi Cancer Hospital Taiyuan Shanxi
China Tianjin Medical University General Hospital Tianjin Tianjin
China The First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China Xinjiang Medical University Cancer Hospital Urumqi Xinjiang
China The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang
China Gansu Wuwei Tumor Hospital Wuwei Gansu
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Fujian Cancer Hospital Xiamen Fujian
China Xuzhou Central Hospital Xuzhou Jiangsu
China Yangzhou FIrst People's Hospital Yangzhou Jiangsu
China Yantai Yuhuangding Hospital Yantai Shandong
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Henan Cancer Hospital Zhengzhou Henan
China Henan Provincial People's Hospital Zhengzhou Henan
China The First Affiliated Hospital of Henan Science&Technology University Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Taizhou Hanzhong biomedical co. LTD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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