HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer
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
1 other identifier
interventional
560
1 country
64
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2020
Typical duration for phase_3
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedStudy Start
First participant enrolled
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2023
CompletedJanuary 28, 2021
January 1, 2021
2.9 years
July 22, 2020
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 36 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 36 months
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 36 months
Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to approximately 36 months
Study Arms (2)
HX008 plus Irinotecan
EXPERIMENTALParticipants recieve HX008 200 mg intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Placebo plus Irinotecan
PLACEBO COMPARATORParticipants recieve placebo intravenous (IV) every 3 weeks (Q3W) plus irinotecan 160 mg/m², IV, Q2W.
Interventions
160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Beijing ChaoYang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Peking University Internationale Hospital
Beijing, Beijing Municipality, 102206, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Xiamen, Fujian, 350000, China
Gansu Wuwei Tumor Hospital
Wuwei, Gansu, 350000, China
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510095, China
Zhongshan People's Hospital
Guangzhou, Guangdong, 528403, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518035, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, 518117, China
Guangxi Medical University Cancer Hospital
Naning, Guangxi, 530021, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangzhou, 510080, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051, China
Affiliated Hospital of Hebei University
Shijiazhuang, Hebei, 071000, China
The affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
The First Affiliated Hospital of Henan Science&Technology University
Zhengzhou, Henan, 471000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 540003, China
The Second Xiangya Hospital of Cancer South University
Changsha, Hunan, 410000, China
Xiangya Hospital, Central South University
Changsha, Hunan, 410000, China
Hunan Cancer Hospital
Changsha, Hunan, 410200, China
The Affiliated People's Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000, China
Changzhou Cancer Hospital
Changzhou, Jiangsu, 213000, China
Jiangsu Provincial Hospital
Nanjing, Jiangsu, 210000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210009, China
Zhongda Hospital Southeast Universtiy
Nanjing, Jiangsu, 210009, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226006, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Yangzhou FIrst People's Hospital
Yangzhou, Jiangsu, 225000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750001, China
Shandong Provincial Hospital
Jinan, Shandong, 250000, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200000, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Hubei Cancer Hospital
Hubei, Wuhan, 430000, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Sir Run Run Shaw Hospital, Medical School of Zhejiang University
Hangzhou, Zhejiang, 310016, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2020
First Posted
July 24, 2020
Study Start
September 16, 2020
Primary Completion
August 10, 2023
Study Completion
August 10, 2023
Last Updated
January 28, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share