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

January 21, 2026 updated by: Ruijin Hospital

Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Resectable Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: A Multicenter, Randomized Phase II-III Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

580

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Baoding, China
        • Affiliated Hospital of Hebei University
      • Beijing, China
        • Cancer Hospital Chinese Academy of Medical Sciences
      • Changsha, China
        • Xiangya Hospital Central South University
      • Changzhi, China
        • Heping Hospital Affiliated to Changzhi Medical College
      • Chengdu, China
        • Sichuan Provincial People's Hospital
      • Chengdu, China
        • Sichuan Cancer Hospital & Institute
      • Guiyang, China
        • The Affiliated Hospital of Guizhou Medical University
      • Haikou, China
        • Hainan Cancer Hospital
      • Hangzhou, China
        • the Second Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, China
        • Cancer Hospital of The University of Chinese Academy of Sciences
      • Hefei, China
        • Hefei Cancer Hospital, Chinese Academy of Sciences
      • Lanzhou, China
        • Lanzhou University Second Hospital
      • Shanghai, China
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Shanghai, China
        • Changhai Hospital
      • Shenyang, China
        • Liaoning Cancer Hospita & Institute
      • Shijiazhuang, China
        • The Fourth Hospital of Hebei Medical University
      • Siping, China
        • Jilin Guowen Hospital
      • Taiyuan, China
        • Shanxi Provincial Cancer Hospital
      • Xi'an, China
        • Tangdu Hospital
      • Xi'an, China
        • First Affiliated Hospital of Xi'an JiaoTong University
      • Yantai, China
        • Yantai Yuhuangding Hospital
      • Zhengzhou, China
        • Henan Provincial Cancer Hospital
      • Zhenjiang, China
        • Affiliated Hospital of Jiangsu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apatinib and Camrelizumab and S-1 and Oxaliplatin
Drug: Apatinib 250mg
Apatinib 250mg
Drug: Camrelizumab
Camrelizumab 200mg
Drug: S-1, Oxaliplatin
S-1, Oxaliplatin, q3w
Experimental: Apatinib and S-1 and Oxaliplatin
Drug: S-1, Oxaliplatin
S-1, Oxaliplatin, q3w
Drug: Apatinib 500mg
Apatinib 500mg
Active Comparator: S-1 and Oxaliplatin
Drug: S-1, Oxaliplatin
S-1, Oxaliplatin, q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological Complete Response (pCR)
Time Frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event-free Survival (EFS)
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
OS
Time Frame: up to 3 years
up to 3 years
Major pathological response(MPR)
Time Frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Margin-free (R0) resection rate
Time Frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
DFS
Time Frame: up to 2 years
up to 2 years
Downstaging of N stage
Time Frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
AEs
Time Frame: Up to approximately 18 months
Up to approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Zhenggang Zhu, Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRAGON - IV
  • Ahead-G208 (Other Identifier: Ruijin Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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