Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer

NCT ID: NCT04208347

Last Updated: 2023-11-14

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Apatinib and Camrelizumab and S-1 and Oxaliplatin

Group Type EXPERIMENTAL

Apatinib 250mg

Intervention Type DRUG

Apatinib 250mg

Camrelizumab

Intervention Type DRUG

Camrelizumab 200mg

S-1, Oxaliplatin

Intervention Type DRUG

S-1, Oxaliplatin, q3w

Apatinib and S-1 and Oxaliplatin

Group Type EXPERIMENTAL

S-1, Oxaliplatin

Intervention Type DRUG

S-1, Oxaliplatin, q3w

Apatinib 500mg

Intervention Type DRUG

Apatinib 500mg

S-1 and Oxaliplatin

Group Type ACTIVE_COMPARATOR

S-1, Oxaliplatin

Intervention Type DRUG

S-1, Oxaliplatin, q3w

Interventions

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Apatinib 250mg

Apatinib 250mg

Intervention Type DRUG

Camrelizumab

Camrelizumab 200mg

Intervention Type DRUG

S-1, Oxaliplatin

S-1, Oxaliplatin, q3w

Intervention Type DRUG

Apatinib 500mg

Apatinib 500mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Xiangya Hospital Central South University

Changsha, , China

Site Status

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, , China

Site Status

Sichuan Cancer Hospital & Institute

Chengdu, , China

Site Status

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status

The Affiliated Hospital of Guizhou Medical University

Guiyang, , China

Site Status

Hainan Cancer Hospital

Haikou, , China

Site Status

Cancer Hospital of the University of Chinese Academy of Sciences

Hangzhou, , China

Site Status

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, , China

Site Status

Hefei Cancer Hospital, Chinese Academy of Sciences

Hefei, , China

Site Status

Lanzhou University Second Hospital

Lanzhou, , China

Site Status

Changhai Hospital

Shanghai, , China

Site Status

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Liaoning Cancer Hospita & Institute

Shenyang, , China

Site Status

The Fourth Hospital of Hebei Medical University

Shijiazhuang, , China

Site Status

Jilin Guowen Hospital

Siping, , China

Site Status

Shanxi Provincial Cancer Hospital

Taiyuan, , China

Site Status

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

Tangdu Hospital

Xi'an, , China

Site Status

Yantai Yuhuangding Hospital

Yantai, , China

Site Status

Henan Provincial Cancer Hospital

Zhengzhou, , China

Site Status

Affiliated Hospital of Jiangsu University

Zhenjiang, , China

Site Status

Countries

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China

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.

Reference Type DERIVED
PMID: 39961962 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39383487 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33490196 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32171104 (View on PubMed)

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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