Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer
NCT ID: NCT04208347
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
580 participants
INTERVENTIONAL
2019-12-18
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Apatinib and Camrelizumab and S-1 and Oxaliplatin
Apatinib 250mg
Apatinib 250mg
Camrelizumab
Camrelizumab 200mg
S-1, Oxaliplatin
S-1, Oxaliplatin, q3w
Apatinib and S-1 and Oxaliplatin
S-1, Oxaliplatin
S-1, Oxaliplatin, q3w
Apatinib 500mg
Apatinib 500mg
S-1 and Oxaliplatin
S-1, Oxaliplatin
S-1, Oxaliplatin, q3w
Interventions
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Apatinib 250mg
Apatinib 250mg
Camrelizumab
Camrelizumab 200mg
S-1, Oxaliplatin
S-1, Oxaliplatin, q3w
Apatinib 500mg
Apatinib 500mg
Eligibility Criteria
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Inclusion Criteria
* Plans to proceed to surgery following pre-operative chemotherapy.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
* Has adequate organ function.
* Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of therapy.
* Has life expectancy of greater than 12 months.
Exclusion Criteria
* Known hypersensitivity to any of the study drugs or excipients.
* Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
* Congenital or acquired immune deficiency (e.g. HIV infected)
18 Years
75 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhenggang Zhu
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Affiliated Hospital of Hebei University
Baoding, , China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, , China
Xiangya Hospital Central South University
Changsha, , China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, , China
Sichuan Cancer Hospital & Institute
Chengdu, , China
Sichuan Provincial People's Hospital
Chengdu, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
Hainan Cancer Hospital
Haikou, , China
Cancer Hospital of the University of Chinese Academy of Sciences
Hangzhou, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Hefei Cancer Hospital, Chinese Academy of Sciences
Hefei, , China
Lanzhou University Second Hospital
Lanzhou, , China
Changhai Hospital
Shanghai, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Liaoning Cancer Hospita & Institute
Shenyang, , China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, , China
Jilin Guowen Hospital
Siping, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Tangdu Hospital
Xi'an, , China
Yantai Yuhuangding Hospital
Yantai, , China
Henan Provincial Cancer Hospital
Zhengzhou, , China
Affiliated Hospital of Jiangsu University
Zhenjiang, , China
Countries
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References
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Yang Z, Yu B, Hu J, Jiang L, Jian M. LRRC25 Is a Potential Biomarker for Predicting Immunotherapy Response in Patients with Gastric Cancer. Dig Dis Sci. 2025 Apr;70(4):1395-1410. doi: 10.1007/s10620-025-08882-7. Epub 2025 Feb 17.
Li C, Tian Y, Zheng Y, Yuan F, Shi Z, Yang L, Chen H, Jiang L, Wang X, Zhao P, Zhang B, Wang Z, Zhao Q, Dong J, Lian C, Xu S, Zhang A, Zheng Z, Wang K, Dang C, Wu D, Chen J, Xue Y, Liang B, Cheng X, Wang Q, Chen L, Xia T, Liu H, Xu D, Zhuang J, Wu T, Zhao X, Wu W, Wang H, Peng J, Hou Z, Zheng R, Chen Y, Yin K, Zhu Z. Pathologic Response of Phase III Study: Perioperative Camrelizumab Plus Rivoceranib and Chemotherapy Versus Chemotherapy for Locally Advanced Gastric Cancer (DRAGON IV/CAP 05). J Clin Oncol. 2025 Feb;43(4):464-474. doi: 10.1200/JCO.24.00795. Epub 2024 Oct 9.
Zheng Y, Wang Z, Yan C, Yan M, Hou Z, Zheng R, Zhu Z, Li C. Protocol for a randomized controlled trial of perioperative S-1 plus oxaliplatin combined with apatinib and camrelizumab in patients with resectable, locally advanced gastric or gastroesophageal junction adenocarcinoma. Ann Transl Med. 2020 Dec;8(24):1684. doi: 10.21037/atm-20-7802.
Zheng Y, Yang X, Yan C, Feng R, Sah BK, Yang Z, Zhu Z, Liu W, Xu W, Ni Z, Beeharry MK, Hua Z, Yan M, Zhu Z, Li C. Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial. Eur J Cancer. 2020 May;130:12-19. doi: 10.1016/j.ejca.2020.02.013. Epub 2020 Mar 11.
Other Identifiers
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Ahead-G208
Identifier Type: OTHER
Identifier Source: secondary_id
DRAGON - IV
Identifier Type: -
Identifier Source: org_study_id
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