Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer
2 other identifiers
interventional
580
1 country
23
Brief Summary
The study is being conducted to evaluate the efficacy, safety and tolerability of chemotherapy and apatinib with or without camrelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2019
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2019
CompletedStudy Start
First participant enrolled
December 18, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 23, 2026
January 1, 2026
7 years
December 18, 2019
January 21, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Pathological Complete Response (pCR)
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event-free Survival (EFS)
Up to approximately 2 years
Secondary Outcomes (6)
Major pathological response(MPR)
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Margin-free (R0) resection rate
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
DFS
up to 2 years
OS
up to 3 years
Downstaging of N stage
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
- +1 more secondary outcomes
Study Arms (3)
Apatinib and Camrelizumab and S-1 and Oxaliplatin
EXPERIMENTALApatinib and S-1 and Oxaliplatin
EXPERIMENTALS-1 and Oxaliplatin
ACTIVE COMPARATORInterventions
S-1, Oxaliplatin, q3w
Eligibility Criteria
You may qualify if:
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0;
- 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.
You may not qualify if:
- Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (23)
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
Related Publications (4)
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.
PMID: 39961962DERIVEDLi 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.
PMID: 39383487DERIVEDZheng 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.
PMID: 33490196DERIVEDZheng 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.
PMID: 32171104DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenggang Zhu
Ruijin Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2019
First Posted
December 23, 2019
Study Start
December 18, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
January 23, 2026
Record last verified: 2026-01