Gastric AdenocarcinomaPhase 2NCT07464756
SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer
A Phase 2 study testing SHR-1701, apatinib and S-1 & Oxaliplatin in people with Gastric Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy 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 Adenocarcinoma
- What is being tested?
- SHR-1701, apatinib and S-1 & Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2026to 31 Jul 2030
- 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
- Patients voluntarily participate in this study and provide signed informed consent;
- Age ≥18 years old;
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);
- Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable
- No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
- Plan to proceed to surgery after completion of neoadjuvant therapy;
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- Able to swallow tablets normally;
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Estimated life expectancy ≥12 months;
- 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 must agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 6 months after chemotherapy (whichever is longer). Male subjects with partners of childbearing potential must be surgically sterile or agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 3 months after chemotherapy (whichever is longer), and must not donate sperm during the study.
Who cannot join
- Known HER2 positive
- Need transthoracic surgical approach Based on the investigator's judgment
- Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4 Presence of unresectable factors, including unresectability due to tumor-related reasons, contraindications to surgery, or refusal of surgery;
- 5. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)； 7. Known hypersensitivity to any of the study drugs or excipients; 8. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 9. Congenital or acquired immune deficiency (e.g. HIV infected)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Xiaofeng Chen
About this study
Official title: A Prospective Exploratory Study of SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
Read the detailed description
This study enroll patients with resectable, locally advanced (cT3-4aN+M0) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received anticancer therapy. Eligible subjects will be randomized in a 1:1 ratio to one of the two intervention arms. Arm 1：SHR-1701, apatinib, and SOX. Arm2: SHR-1701 and SOX. Arm 1 incorporates a safety run-in phase, during which the first 6 subjects enrolled in this cohort will undergo safety observation.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- SHR-1701, apatinib, S-1 & Oxaliplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701Drug
SHR-1701, 1800mg, Q3w
apatinibDrug
apatinib 250mg，Q3W
S-1 & OxaliplatinDrug
S-1, Oxaliplatin, Q3w
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701, apatinib, and SOX | Experimental | Not described Receives: Drug: SHR-1701; Drug: apatinib; Drug: S-1 & Oxaliplatin |
| SHR-1701 and SOX | Experimental | Not described Receives: Drug: SHR-1701; 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 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Secondary outcomes (7)
Tumor Regression Grade (TRG)
Measured: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
ypN staging
Measured: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
R0 resection rate
Measured: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event free survival (EFS)
Measured: Up to approximately 4 years
Disease-free survival (DFS)
Measured: Up to approximately 4 years
Overall survival(OS)
Measured: Up to approximately 4 years
AEs
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start3 Apr 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464756
- Sponsor's protocol ID
- MA-GC-II-028
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Exploratory Study of SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07464756
- Acronym / sponsor ID
- MA-GC-II-028
- Conditions
- Gastric Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 11 Mar 2026 (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, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
Detailed description
This study enroll patients with resectable, locally advanced (cT3-4aN+M0) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received anticancer therapy. Eligible subjects will be randomized in a 1:1 ratio to one of the two intervention arms. Arm 1：SHR-1701, apatinib, and SOX. Arm2: SHR-1701 and SOX. Arm 1 incorporates a safety run-in phase, during which the first 6 subjects enrolled in this cohort will undergo safety observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1701, apatinib, and SOX | Experimental | Drug: SHR-1701, Drug: apatinib, Drug: S-1 & Oxaliplatin |
| SHR-1701 and SOX | Experimental | Drug: SHR-1701, 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 (11 listed)
- Patients voluntarily participate in this study and provide signed informed consent;
- Age ≥18 years old;
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);
- Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable
- No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
Key exclusion criteria (4 listed)
- Known HER2 positive
- Need transthoracic surgical approach Based on the investigator's judgment
- Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4 Presence of unresectable factors, including unresectability due to tumor-related reasons, contraindications to surgery, or refusal of surgery;
- 5. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)； 7. Known hypersensitivity to any of the study drugs or excipients; 8. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 9. 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 |
|---|---|---|
| SHR-1701SHR-1701, 1800mg, Q3w | Drug | SHR-1701 and SOX, SHR-1701, apatinib, and SOX |
| apatinibapatinib 250mg，Q3W | Drug | SHR-1701, apatinib, and SOX |
| S-1 & OxaliplatinS-1, Oxaliplatin, Q3w | Drug | SHR-1701 and SOX, SHR-1701, apatinib, and SOX |
Primary outcome
Pathological Complete Response (pCR)
Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
7 secondary outcomes
Tumor Regression Grade (TRG)
Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
ypN staging
Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
R0 resection rate
Time frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event free survival (EFS)
Time frame: Up to approximately 4 years
Disease-free survival (DFS)
Time frame: Up to approximately 4 years
Overall survival(OS)
Time frame: Up to approximately 4 years
AEs
Time frame: Up to approximately 3 years
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 16 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHR-1701, apatinib and S-1 & Oxaliplatin in people with Gastric Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 11 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Xiaofeng Chen, MD (0086-13585172066, chenxiaofengnimu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: Up to 9 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 16 Jul 2026.