Gastric and Gastroesophageal Junction (GEJ) AdenocarcinomaPhase 2/3NCT04208347
Perioperative Treatment of Combined SOX With Apatinib and Camrelizumab for Oesophagogastric Cancer
A Phase 2/3 study testing Apatinib 250mg, Camrelizumab and S-1, Oxaliplatin in people with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Ruijin Hospital at 23 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- Apatinib 250mg, Camrelizumab and S-1, Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 23 sitesChina
- Study dates
- 18 Dec 2019to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Affiliated Hospital of Hebei University
Baoding
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Xiangya Hospital Central South University
Changsha
Heping Hospital Affiliated to Changzhi Medical College
Changzhi
Sichuan Cancer Hospital & Institute
Chengdu
Sichuan Provincial People's Hospital
Chengdu
The Affiliated Hospital of Guizhou Medical University
Guiyang
Hainan Cancer Hospital
Haikou
Cancer Hospital of the University of Chinese Academy of Sciences
Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Hefei Cancer Hospital, Chinese Academy of Sciences
Hefei
Lanzhou University Second Hospital
Lanzhou
Changhai Hospital
Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Liaoning Cancer Hospita & Institute
Shenyang
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Jilin Guowen Hospital
Siping
Shanxi Provincial Cancer Hospital
Taiyuan
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Tangdu Hospital
Xi'an
Yantai Yuhuangding Hospital
Yantai
Henan Provincial Cancer Hospital
Zhengzhou
Affiliated Hospital of Jiangsu University
Zhenjiang
About this study
Official title: 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.
- Being tested
- Apatinib 250mg, Camrelizumab, S-1, Oxaliplatin, Apatinib 500mg
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib 250mgDrug
Apatinib 250mg
CamrelizumabDrug
Camrelizumab 200mg
S-1, OxaliplatinDrug
S-1, Oxaliplatin, q3w
Apatinib 500mgDrug
Apatinib 500mg
| Study group | Role | What they receive |
|---|---|---|
| Apatinib and Camrelizumab and S-1 and Oxaliplatin | Experimental | Not described Receives: Drug: Apatinib 250mg; Drug: Camrelizumab; Drug: S-1, Oxaliplatin |
| Apatinib and S-1 and Oxaliplatin | Experimental | Not described Receives: Drug: S-1, Oxaliplatin; Drug: Apatinib 500mg |
| S-1 and Oxaliplatin | Active comparator | Not described Receives: Drug: S-1, Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Measured: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event-free Survival (EFS)
Measured: Up to approximately 2 years
Secondary outcomes (6)
Major pathological response(MPR)
Measured: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Margin-free (R0) resection rate
Measured: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
DFS
Measured: up to 2 years
OS
Measured: up to 3 years
Downstaging of N stage
Measured: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
AEs
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start18 Dec 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric and Gastroesophageal Junction (GEJ) AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenggang Zhu, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208347
- Sponsor's protocol ID
- DRAGON - IV
- Other IDs
- Ahead-G208
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2019
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 39961962Li 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 39383487Zheng 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 33490196Zheng 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04208347
- Acronym / sponsor ID
- DRAGON - IV
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apatinib and Camrelizumab and S-1 and Oxaliplatin | Experimental | Drug: Apatinib 250mg, Drug: Camrelizumab, Drug: S-1, Oxaliplatin |
| Apatinib and S-1 and Oxaliplatin | Experimental | Drug: S-1, Oxaliplatin, Drug: Apatinib 500mg |
| S-1 and Oxaliplatin | Active comparator | Drug: S-1, Oxaliplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib 250mgApatinib 250mg | Drug | Apatinib and Camrelizumab and S-1 and Oxaliplatin |
| CamrelizumabCamrelizumab 200mg | Drug | Apatinib and Camrelizumab and S-1 and Oxaliplatin |
| S-1, OxaliplatinS-1, Oxaliplatin, q3w | Drug | Apatinib and Camrelizumab and S-1 and Oxaliplatin, Apatinib and S-1 and Oxaliplatin, S-1 and Oxaliplatin |
| Apatinib 500mgApatinib 500mg | Drug | Apatinib and S-1 and Oxaliplatin |
Primary outcome
Pathological Complete Response (pCR)
Time frame: 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
6 secondary outcomes
Major pathological response(MPR)
Time frame: 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
DFS
Time frame: up to 2 years
OS
Time frame: up to 3 years
Downstaging of N stage
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 39961962Yang 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.
- Derived from this study: PubMed 39383487Li 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.
- Derived from this study: PubMed 33490196Zheng 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.
- Derived from this study: PubMed 32171104Zheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenggang Zhu principal investigator
Ruijin Hospital
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Apatinib 250mg, Camrelizumab and S-1, Oxaliplatin in people with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Ruijin Hospital at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208347, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.