Gastric Cancer or Gastroesophageal Junction AdenocarcinomaPhase 2NCT07492615
A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Sintilimab and S-1 & Oxaliplatin in people with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, run by Fudan University at 1 site in China.
Trial summary
This study aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR/MSI-H pIIIA/IIIB stage gastric/gastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Sintilimab and S-1 & Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2026to 20 Feb 2033
- 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
- Signed written informed consent.
- Male or female, age ≥18 years.
- Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
- Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB.
- Diagnosed with mismatch repair deficiency (dMMR) by immunohistochemistry (IHC) of biopsy tissue or microsatellite instability-high (MSI-H) by genetic sequencing.
- Underwent D2 or more extensive radical resection and achieved R0 resection.
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- Able to swallow tablets normally.
- ECOG performance status 0-1.
- Life expectancy >6 months.
- Adequate organ function, subjects must meet the following laboratory criteria:
- Absolute neutrophil count (ANC) ≥1.5×10^9/L without granulocyte colony-stimulating factor within the past 14 days.
- Platelets ≥100×10^9/L without transfusion within the past 14 days.
- Hemoglobin >9 g/dL without transfusion or erythropoietin use within the past 14 days.
- Total bilirubin ≤1.5×ULN; if total bilirubin >1.5×ULN but direct bilirubin ≤ULN, enrollment is also permitted.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN.
- Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min.
- Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.
- Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range may also be enrolled.
- Cardiac enzyme panel within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are also permitted for enrollment).
- For female subjects of childbearing potential, a urine or serum pregnancy test must be negative within 3 days prior to the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential is defined as postmenopausal for at least 1 year, or surgically sterile or hysterectomy.
- If at risk of conception, all subjects (male or female) must use contraceptive measures with a failure rate of <1% per year throughout the treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy).
Who cannot join
- Cancers involving the EGJ with the tumor center located in the proximal stomach ≤2 cm from the EGJ.
- Diagnosis of any other malignant disease other than gastric cancer within 5 years prior to first dose (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ).
- Currently participating in interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to first dose.
- Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).
- Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferons, interleukins, except for local use to control pleural effusion) within 2 weeks prior to first dose.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.
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- Receiving systemic corticosteroid therapy (excluding nasal spray, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to first dose.
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known allergy to any drug used in this study.
- Has not adequately recovered from toxicities and/or complications caused by any prior intervention prior to starting treatment (i.e., ≤ grade 1 or returned to baseline, excluding fatigue or alopecia).
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive).
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number above the upper limit of normal of the testing laboratory at the study site). Subjects meeting the following criteria may also be enrolled:
- HBV viral load <1000 copies/ml (200 IU/ml) prior to first dose, subjects should receive anti-HBV therapy during the entire study chemotherapy treatment to prevent reactivation.
- For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is needed.
- Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection).
- Received a live vaccine within 30 days prior to first dose (Cycle 1, Day 1).
- Pregnant or breastfeeding women.
- Presence of any severe or uncontrolled systemic disease, such as:
- Abnormalities in resting ECG in rhythm, conduction, or morphology that are significant and severely symptomatic and difficult to control, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation.
- Unstable angina, congestive heart failure, chronic heart failure with New York Heart Association (NYHA) class ≥2.
- Any arterial thrombotic, embolic, or ischemic event within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
- Uncontrolled hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg).
- History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to first dose, or current clinically active interstitial lung disease.
- Active pulmonary tuberculosis.
- Active or uncontrolled infection requiring systemic therapy.
- Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction.
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis.
- Poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L).
- Urinalysis indicates proteinuria ≥++ and confirmed 24-hour urine protein quantification >1.0 g.
- Patients with mental disorders who are unable to comply with treatment.
- History or evidence of disease, treatment, or laboratory abnormalities that may interfere with the study results, hinder the subject's full participation in the study, or other conditions that the investigator deems unsuitable for enrollment, or the investigator believes there are other potential risks that make participation inappropriate.
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200230
Xiaowen Liu, 18017317145, liuxw1129@hotmail.com
About this study
Official title: Sintilimab Combined With SOX Versus SOX as Adjuvant Therapy for Patients With Stage pIIIC or dMMR/MSI-H Stage pIIIA/IIIB Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Randomized Controlled Phase II Clinical Trial
This study aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR/MSI-H pIIIA/IIIB stage gastric/gastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study. Patients will be randomly assigned in a 1:1 ratio to receive up to 8 cycles of sintilimab combined with SOX or SOX alone as adjuvant therapy.
Read the detailed description
This is a single-center, randomized controlled phase II clinical study.The primary endpoint was 3-year disease-free survival (3yr-DFS). The secondary endpoints were disease-free survival (DFS), overall survival (OS), and safety. The study used RECIST v1.1 for imaging assessment. Tumor imaging evaluations were conducted every 12 weeks (±7 days) until disease recurrence, death, or up to 24 months, and then every 24 weeks (±7 days) thereafter. The same imaging technique should be used for the same subject throughout the study period. Safety follow-up was from the first treatment to 30 days after the last treatment.
- Being tested
- Sintilimab, S-1 & Oxaliplatin
- Keywords
- Gastrci cancer or Gastroesophageal Junction Adenocarcinoma, Adjuvent Therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
200 mg, administered intravenously, d1, every 3 weeks
S-1 & OxaliplatinDrug
S-1:Oral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks. Oxaliplatin: 130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab and SOX | Experimental | Not described Receives: Drug: Sintilimab; Drug: S-1 & Oxaliplatin |
| SOX | 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.
3-year disease-free survival (3yr-DFS)
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.
Measured: Up to 3 years after surgery
Secondary outcomes (3)
disease-free survival (DFS)
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment.
Measured: Up to 5 years after surgery
Overall Survival(OS)
OS is defined as the time from the date of randomisation until death due to any cause.
Measured: Up to 7 years after enrollment
Adverse events(all grades）
Measured: From the first dose of system therapy up to 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start29 Jan 2026
- Primary completion20 Feb 2029 (estimated)
- Study completion20 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fenglin Liu, Fudan University
- Investigators
- Xiaowen Liu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492615
- Sponsor's protocol ID
- 2511333-9
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 25 Mar 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With SOX Versus SOX as Adjuvant Therapy for Patients With Stage pIIIC or dMMR/MSI-H Stage pIIIA/IIIB Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Randomized Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07492615
- Acronym / sponsor ID
- 2511333-9
- Keywords
- Gastrci cancer or Gastroesophageal Junction Adenocarcinoma, Adjuvent Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 20 Feb 2029 (estimated)
- Study completion
- 20 Feb 2033 (estimated)
- First posted
- 25 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 aims to explore the efficacy and safety of sintilimab combined with SOX versus SOX alone as adjuvant therapy for patients with pIIIC stage or dMMR/MSI-H pIIIA/IIIB stage gastric/gastroesophageal junction adenocarcinoma. A total of 276 subjects are planned to be enrolled in this study. Patients will be randomly assigned in a 1:1 ratio to receive up to 8 cycles of sintilimab combined with SOX or SOX alone as adjuvant therapy.
Detailed description
This is a single-center, randomized controlled phase II clinical study.The primary endpoint was 3-year disease-free survival (3yr-DFS). The secondary endpoints were disease-free survival (DFS), overall survival (OS), and safety. The study used RECIST v1.1 for imaging assessment. Tumor imaging evaluations were conducted every 12 weeks (±7 days) until disease recurrence, death, or up to 24 months, and then every 24 weeks (±7 days) thereafter. The same imaging technique should be used for the same subject throughout the study period. Safety follow-up was from the first treatment to 30 days after the last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab and SOX | Experimental | Drug: Sintilimab, Drug: S-1 & Oxaliplatin |
| SOX | Active comparator | 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 (21 listed)
- Signed written informed consent.
- Male or female, age ≥18 years.
- Histopathologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ).
- Diagnosed with pTNM stage IIIC or pTNM stage IIIA/IIIB.
- Diagnosed with mismatch repair deficiency (dMMR) by immunohistochemistry (IHC) of biopsy tissue or microsatellite instability-high (MSI-H) by genetic sequencing.
Key exclusion criteria (31 listed)
- Cancers involving the EGJ with the tumor center located in the proximal stomach ≤2 cm from the EGJ.
- Diagnosis of any other malignant disease other than gastric cancer within 5 years prior to first dose (excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ).
- Currently participating in interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to first dose.
- Prior receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.).
- Received systemic therapy with Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferons, interleukins, except for local use to control pleural effusion) within 2 weeks prior to first dose.
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 |
|---|---|---|
| Sintilimab200 mg, administered intravenously, d1, every 3 weeks | Drug | Sintilimab and SOX |
| S-1 & OxaliplatinS-1:Oral, 40-60 mg, twice daily (bid), d1-14, every 3 weeks. Oxaliplatin: 130 mg/m², administered intravenously on Day 1 (d1), every 3 weeks. | Drug | SOX, Sintilimab and SOX |
Primary outcome
3-year disease-free survival (3yr-DFS)
Time frame: Up to 3 years after surgery
DFS is defined as time from randomization to disease recurrence (determined by CT or MRI scan and/or pathologic disease on biopsy) or death (from any cause) by investigator assessment. 3-year DFS rate is Disease-Free Survival at 3 Years.
3 secondary outcomes
disease-free survival (DFS)
Time frame: Up to 5 years after surgery
Overall Survival(OS)
Time frame: Up to 7 years after enrollment
Adverse events(all grades）
Time frame: From the first dose of system therapy up to 90 days after the last dose
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 25 Mar 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.
Xiaowen Liu principal investigator
Fudan University
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 Sintilimab and S-1 & Oxaliplatin in people with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, run by Fudan 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 21 inclusion and 31 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 25 Mar 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 Xiaowen Liu (18017317145, liuxw1129@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival (3yr-DFS) (time frame: Up to 3 years after surgery). 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 25 Mar 2026.