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Active, not recruitingNCT04208347Updated Jan 23, 2026

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

A Phase 2/3 interventional study of Apatinib 250mg and Camrelizumab in Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, sponsored by Ruijin Hospital. Active, not recruiting at 23 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Ruijin Hospital · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
580
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

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In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 580 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
580 participants (estimated)

Study arms

  • Experimental
    Apatinib and Camrelizumab and S-1 and Oxaliplatin

    Drug: Apatinib 250mg · Drug: Camrelizumab · Drug: S-1, Oxaliplatin

  • Experimental
    Apatinib and S-1 and Oxaliplatin

    Drug: S-1, Oxaliplatin · Drug: Apatinib 500mg

  • Active comparator
    S-1 and Oxaliplatin

    Drug: S-1, Oxaliplatin

Interventions

  • DrugApatinib 250mg

    Apatinib 250mg

  • DrugCamrelizumab

    Camrelizumab 200mg

  • DrugS-1, Oxaliplatin

    S-1, Oxaliplatin, q3w

  • DrugApatinib 500mg

    Apatinib 500mg

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What researchers measure

Primary outcomes

  1. Pathological Complete Response (pCR)

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  2. Event-free Survival (EFS)

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Major pathological response(MPR)

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  2. Margin-free (R0) resection rate

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  3. DFS

    Time frame: up to 2 years

  4. OS

    Time frame: up to 3 years

  5. Downstaging of N stage

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  6. AEs

    Time frame: Up to approximately 18 months

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Study locations

23 sites
  • 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
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References and documents

Publications

  • 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. PubMed 39961962 ↗
  • 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. PubMed 39383487 ↗
  • 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. PubMed 33490196 ↗
  • 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. PubMed 32171104 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04208347
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Dec 23, 2019
Start date
Dec 18, 2019
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jan 23, 2026

Study contacts

Zhenggang Zhu
principal investigator · Ruijin Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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