Gastric Adenocarcinoma and Gastroesophageal Junction AdenocarcinomaPhase 2NCT07384234
SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis
A Phase 2 study testing SHR-1701, Capecitabine and S-1 in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Ruijin Hospital at 2 sites in China.
Trial summary
This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- SHR-1701, Capecitabine and S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 24 Apr 2026to 30 Dec 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
- Age ≥ 18 years old.
- Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion).
- Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian metastasis is permitted), and without gastric outlet obstruction or intestinal obstruction.
- No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Normal function of major organs.
Who cannot join
- Known HER2-positive.
- Previous history of gastric cancer surgery.
- Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.
- Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).
- Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease.
- Significant cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality
Kai Yin, kyin67@smmu.edu.cn
Kai Yin
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai
Yanan Zheng, +8613636404065, ianzyn@163.com
Yanan Zheng
About this study
Official title: SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: an Exploratory Study
This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.
- Being tested
- SHR-1701, Capecitabine, S-1, Paclitaxel, 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
CapecitabineDrug
Capecitabine, Q3W
S-1Drug
S-1, Q3W
PaclitaxelDrug
Paclitaxel,Q3W
OxaliplatinDrug
Oxaliplatin, Q3W
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1 | Experimental | Not described Receives: Drug: SHR-1701; Drug: S-1; Drug: Paclitaxel |
| SHR-1701 and CAPOX | Experimental | Not described Receives: Drug: SHR-1701; Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year overall survival rate
Measured: Up to 2 years
Secondary outcomes (8)
Conversion surgery rate
Measured: Up to 4 weeks after completion of surgery
R0 resection rate
Measured: Up to 4 weeks after completion of surgery
Pathological complete response(pCR)
Measured: Up to 4 weeks after completion of surgery
Tumor regression grade
Measured: Up to 4 weeks after completion of surgery
Event free survival (EFS)
Measured: Up to 2 years
DFS
Disease-free survival (DFS)
Measured: Up to 2 years
Overall survival(OS)
Measured: Up to 3 years
AEs
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start24 Apr 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Adenocarcinoma and Gastroesophageal Junction 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanan Zheng, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384234
- Sponsor's protocol ID
- MA-GC-II-026
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2026
- Last updated
- 23 Jul 2026
- Results posted
- 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: an Exploratory Study
- ClinicalTrials.gov ID
- NCT07384234
- Acronym / sponsor ID
- MA-GC-II-026
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 3 Feb 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 prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1 | Experimental | Drug: SHR-1701, Drug: S-1, Drug: Paclitaxel |
| SHR-1701 and CAPOX | Experimental | Drug: SHR-1701, Drug: Capecitabine, Drug: 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)
- Age ≥ 18 years old.
- Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion).
- Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian metastasis is permitted), and without gastric outlet obstruction or intestinal obstruction.
- No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Key exclusion criteria (6 listed)
- Known HER2-positive.
- Previous history of gastric cancer surgery.
- Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.
- Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).
- Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease.
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 CAPOX, SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1 |
| CapecitabineCapecitabine, Q3W | Drug | SHR-1701 and CAPOX |
| S-1S-1, Q3W | Drug | SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1 |
| PaclitaxelPaclitaxel,Q3W | Drug | SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1 |
| OxaliplatinOxaliplatin, Q3W | Drug | SHR-1701 and CAPOX |
Primary outcome
2-year overall survival rate
Time frame: Up to 2 years
8 secondary outcomes
Conversion surgery rate
Time frame: Up to 4 weeks after completion of surgery
R0 resection rate
Time frame: Up to 4 weeks after completion of surgery
Pathological complete response(pCR)
Time frame: Up to 4 weeks after completion of surgery
Tumor regression grade
Time frame: Up to 4 weeks after completion of surgery
Event free survival (EFS)
Time frame: Up to 2 years
DFS
Time frame: Up to 2 years
Overall survival(OS)
Time frame: Up to 3 years
AEs
Time frame: Up to 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 23 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.
Yanan Zheng principal investigator
Ruijin Hospital
2 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 SHR-1701, Capecitabine and S-1 in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Ruijin Hospital at 2 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 6 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 23 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 2 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?
Contact Yanan Zheng (+8613636404065, ianzyn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year overall survival rate (time frame: Up to 2 years). 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 23 Jul 2026.