HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

Stomach Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486651
• Other study ID #: HX008-III-GC-01
• Status: Recruiting
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Stomach Cancer
• Stomach Neoplasms

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