Gastric and Gastroesophageal Junction (GEJ) AdenocarcinomaPhase 2NCT06693128
Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Gastric Cancer
A Phase 2 study testing Camrelizumab, Apatinib and S-1, Oxaliplatin in people with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Ruijin Hospital at 3 sites in China.
Trial summary
This study is a multicenter, randomized, uncontrolled clinical trial to evaluate the efficacy and safety of camrelizumab combined with or without apatinib and SOX of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- Camrelizumab, Apatinib and S-1, Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesChina
- Study dates
- 21 Nov 2024to 31 Dec 2027
- Phase
- Phase 2
- 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 years and older
- 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 (according to AJCC 8th edition) ;
- Plans to proceed to surgery after completion of neoadjuvant therapy;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Has adequate organ function.
- Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, and be willing to use a highly effective method of contraception during the study and for 2 months after the last dose of carrelizumab or 8 weeks after apatinib or 6 months after chemotherapy drugs, whichever is longer.
- Male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use highly effective methods of contraception during the study and for 2 months after the last administration of carrilizumab or 8 weeks after apatinib or 3 months after chemotherapy drugs, whichever is longer. Sperm donation is not allowed during the study.
Who cannot join
- Known HER2 positive;
- Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);
- Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast;
- 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
3 sites in 1 country.
China3 sites
Sichuan Cancer Hospital & Institute
Chengdu
Changhai Hospital
Shanghai
Yantai Yuhuangding Hospital
Yantai
About this study
Official title: Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Prospective, Exploratory II Trial
This study is a multicenter, randomized, uncontrolled clinical trial to evaluate the efficacy and safety of camrelizumab combined with or without apatinib and SOX of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
- Being tested
- Camrelizumab, Apatinib, S-1, Oxaliplatin
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab 200mg
ApatinibDrug
Apatinib 250mg
S-1, OxaliplatinDrug
S-1, Oxaliplatin, q3w
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab and Apatinib and S-1 and Oxaliplatin | Experimental | Not described Receives: Drug: Camrelizumab; Drug: Apatinib; Drug: S-1, Oxaliplatin |
| Camrelizumab and S-1 and Oxaliplatin | Experimental | Not described Receives: Drug: Camrelizumab; 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)
Defined as the percentage of subjects with no residual tumor cells in the primary tumor (Becker Grade 1a)
Measured: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Secondary outcomes (8)
Major pathological response (MPR)
Measured: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
total Pathologic complete response (tpCR)
Measured: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
R0 resection rate
Measured: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Pathologic Nodal Stage after Neoadjuvant Therapy
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 3 years
Disease-free survival (DFS)
Measured: Up to approximately 3 years
Overall survival(OS)
Measured: Up to approximately 5 years
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 posted18 Nov 2024
- Study start21 Nov 2024
- Primary completion30 May 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenggang Zhu, Principal investigator, Ruijin HospitalYantao Tian, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693128
- Sponsor's protocol ID
- MA-GC-II-019
- Status last verified
- Jan 2026
- First submitted
- 14 Nov 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Prospective, Exploratory II Trial
- ClinicalTrials.gov ID
- NCT06693128
- Acronym / sponsor ID
- MA-GC-II-019
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Nov 2024 (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.
This study is a multicenter, randomized, uncontrolled clinical trial to evaluate the efficacy and safety of camrelizumab combined with or without apatinib and SOX of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab and Apatinib and S-1 and Oxaliplatin | Experimental | Drug: Camrelizumab, Drug: Apatinib, Drug: S-1, Oxaliplatin |
| Camrelizumab and S-1 and Oxaliplatin | Experimental | Drug: Camrelizumab, Drug: S-1, Oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0 (according to AJCC 8th edition) ;
- Plans to proceed to surgery after completion of neoadjuvant therapy;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Has adequate organ function.
- Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, and be willing to use a highly effective method of contraception during the study and for 2 months after the last dose of carrelizumab or 8 weeks after apatinib or 6 months after chemotherapy drugs, whichever is longer.
Key exclusion criteria (7 listed)
- Known HER2 positive;
- Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);
- Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast;
- Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)；
- Known hypersensitivity to any of the study drugs or excipients;
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 |
|---|---|---|
| CamrelizumabCamrelizumab 200mg | Drug | Camrelizumab and Apatinib and S-1 and Oxaliplatin, Camrelizumab and S-1 and Oxaliplatin |
| ApatinibApatinib 250mg | Drug | Camrelizumab and Apatinib and S-1 and Oxaliplatin |
| S-1, OxaliplatinS-1, Oxaliplatin, q3w | Drug | Camrelizumab and Apatinib and S-1 and Oxaliplatin, Camrelizumab 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
Defined as the percentage of subjects with no residual tumor cells in the primary tumor (Becker Grade 1a)
8 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
total Pathologic complete response (tpCR)
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
R0 resection rate
Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Pathologic Nodal Stage after Neoadjuvant Therapy
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 3 years
Disease-free survival (DFS)
Time frame: Up to approximately 3 years
Overall survival(OS)
Time frame: Up to approximately 5 years
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 28 Jan 2026.
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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
Yantao Tian principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, Apatinib and S-1, Oxaliplatin in people with Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by Ruijin Hospital at 3 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 6 inclusion and 7 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 28 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 3 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 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.
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.