Gastric AdenocarcinomaPhase 2ARTEMIS-GC3NCT07263386
A Phase II, Multicenter, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Sintilimab Plus SOX Versus SOX Alone as Adjuvant Therapy for PD-L1-Positive, Stage pN3 Gastric Cancer
A Phase 2 study testing Sintilimab and SOX Chemotherapy in people with Gastric Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study intends to enroll gastric cancer patients who are PD-L1 positive and pathologically confirmed as Stage N3. Enrolled patients will be randomly assigned to receive either standard adjuvant SOX regimen or SOX regimen combined with sintilimab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Sintilimab and SOX Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2025to Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent form prior to the initiation of any study-related procedures.
- Aged between 18 and 75 years.
- Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status.
- No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery.
- Histopathologically confirmed gastric adenocarcinoma.
- Pathological stage classified as TxN3M0 according to the 8th edition of the AJCC Cancer Staging Manual.
Show all 19Show fewer
- PD-L1 Combined Positive Score (CPS) ≥ 1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Expected survival time ≥ 6 months.
- Adequate organ function, with subjects meeting the following laboratory criteria before enrollment:
- Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L without the use of granulocyte colony-stimulating factor (G-CSF) within the past 14 days.
- Platelet count ≥ 100×10⁹/L without blood transfusion within the past 14 days. Hemoglobin > 9 g/dL without blood transfusion or use of erythropoietin within the past 14 days.
- Total bilirubin ≤ 1.5×Upper Limit of Normal (ULN); subjects with total bilirubin > 1.5×ULN but direct bilirubin ≤ ULN are also eligible.
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5×ULN. Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 60 mL/min.
- Adequate 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 the normal range. Subjects with baseline TSH outside the normal range are eligible if total T3 (or free T3, FT3) and free T4 (FT4) are within the normal range.
- Myocardial enzyme profile within the normal range (subjects with isolated laboratory abnormalities deemed clinically insignificant by the investigator are also eligible).
- For female subjects of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days before the first administration of the study drug (Cycle 1, Day 1). A blood pregnancy test is required if the urine pregnancy test result is inconclusive. Non-childbearing potential is defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.
- All subjects (male and female) at risk of conception must use contraceptive methods with a yearly failure rate of less than 1% throughout the treatment period and until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy drugs).
Who cannot join
- Pathologically confirmed as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, neuroendocrine tumor, or gastrointestinal stromal tumor (mixed carcinoma with adenocarcinoma component > 80% is eligible for enrollment).
- Diagnosis of malignant diseases other than gastric cancer within 5 years before the first dose administration (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, differentiated thyroid cancer, and/or radically resected carcinoma in situ).
- Currently participating in therapeutic clinical research, or having received other study drugs within 4 weeks before the first dose administration.
- Previous receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.).
- Receipt of Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) via systemic treatment within 2 weeks before the first dose administration.
- History of active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first dose administration. Replacement therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.
Show all 26Show fewer
- Receipt of systemic glucocorticoid therapy (excluding nasal, inhaled, or other forms of topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose administration of the study; Note: - - Use of physiological doses of glucocorticoids (≤ 10 mg/day prednisone or equivalent drugs) is allowed.
- Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known history of allergy to drugs used in this study.
- Failure to fully recover from toxicity and/or complications caused by any intervention before the start of treatment (i.e., ≤ Grade 1 or return to baseline, excluding fatigue or alopecia).
- Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies).
- Untreated active hepatitis B (defined as positive HBsAg with HBV-DNA copy number exceeding the upper limit of normal value of the laboratory in the research center); Note: Hepatitis B subjects meeting the following criteria are also eligible: HBV viral load < 1000 copies/ml (200 IU/ml) before the first dose administration, and subjects should receive anti-HBV treatment during the entire study chemotherapy period to avoid viral reactivation. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and negative HBV viral load, prophylactic anti-HBV treatment is not required, but close monitoring of viral reactivation is necessary.
- Subjects with active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection).
- Receipt of live vaccines within 30 days before the first dose administration (Cycle 1, Day 1); Note: Receipt of inactivated influenza vaccines via injection within 30 days before the first dose administration is allowed, but intranasal attenuated live influenza vaccines are not allowed.
- Pregnant or lactating women.
- Presence of any severe or uncontrolled systemic diseases, such as:
- Significant and poorly controlled abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation.
- Unstable angina pectoris, congestive heart failure, or chronic heart failure with New York Heart Association (NYHA) classification ≥ Grade 2.
- Any arterial thrombosis, embolism, or ischemia (e.g., myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack) within 6 months before enrollment.
- Poorly controlled blood pressure (systolic blood pressure > 140 mmHg and diastolic blood pressure > 90 mmHg despite medication).
- History of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose administration, or current clinically active interstitial lung disease.
- Active pulmonary tuberculosis. Presence of active or uncontrolled infection requiring systemic treatment. Presence of clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
- Liver diseases such as cirrhosis, decompensated liver disease, and acute or chronic active hepatitis.
- Poorly controlled diabetes mellitus (fasting blood glucose (FBG) > 10 mmol/L). Urinalysis indicating urine protein ≥ ++, and confirmed 24-hour urine protein > 1.0 g.
- Patients with mental disorders who are unable to cooperate with treatment.
- Presence of medical history, evidence of disease, treatment, or abnormal laboratory test results that may interfere with study results, prevent the subject from completing the study, or other circumstances deemed unsuitable for enrollment by the investigator, or other potential risks deemed unsuitable for participation in this study by the investigator.
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 with Nanjing Medical University
Nanjing, Jiangsu, 210029
Xu Hao, M.D Ph.D, 025-68306505, Hxu@njmu.edu.cn
About this study
This study intends to enroll gastric cancer patients who are PD-L1 positive and pathologically confirmed as Stage N3. Enrolled patients will be randomly assigned to receive either standard adjuvant SOX regimen or SOX regimen combined with sintilimab. The objective of the study is to determine whether adding a PD-1 inhibitor to postoperative chemotherapy can improve the Disease-Free Survival (DFS) rate in patients with Stage N3 gastric cancer.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Sintilimab, SOX Chemotherapy
- Keywords
- PD-1 inhibitor, adjuvant therapy, Sintilimab, Gastric Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
For patients with body weight < 60 kg, the dose is 3 mg/kg, administered via intravenous infusion (i.v.gtt.) on Day 1; for patients with body weight ≥ 60 kg, a fixed dose of 200 mg is administered via intravenous infusion (i.v.gtt.) on Day 1. The treatment is repeated every 21 days.
SOX ChemotherapyDrug
S-1: 40 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days.
Oxaliplatin: 130 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab + SOX | Active comparator | Patients will first receive 6 to 8 cycles of treatment with sintilimab + SOX; sintilimab will subsequently be continued as maintenance therapy for up to one year. Receives: Drug: Sintilimab; Drug: SOX Chemotherapy |
| SOX | Active comparator | Patients will receive 6 to 8 cycles of treatment with SOX Receives: Drug: SOX Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS)
Defined from the date of completion of curative-intent treatment (e.g., surgery, adjuvant chemotherapy) to the date of first documentation of disease recurrence (e.g., tumor relapse, metastasis) or death from any cause, whichever occurs first.
Measured: 3 years
Secondary outcomes (3)
Overall Survival (OS)
Defined from date of recruit to date of first documentation of death from any cause or censored at the date of the last follow-up.
Measured: 5 years
Incidence rate of adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0
Measured: 3 years
Serious adverse events (SAE)
Serious adverse events (SAE) is defined as either death, life-threatening, or Permanent or severe disability/incapacity.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start23 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 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
- 460 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263386
- Sponsor's protocol ID
- 2025-SR-859
- Acronym
- ARTEMIS-GC3
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Controlled Clinical Study Comparing the Efficacy and Safety of Sintilimab Plus SOX Versus SOX Alone as Adjuvant Therapy for PD-L1-Positive, Stage pN3 Gastric Cancer
- ClinicalTrials.gov ID
- NCT07263386
- Acronym / sponsor ID
- ARTEMIS-GC3 / 2025-SR-859
- Conditions
- Gastric Adenocarcinoma
- Keywords
- PD-1 inhibitor, adjuvant therapy, Sintilimab, Gastric Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 4 Dec 2025 (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 intends to enroll gastric cancer patients who are PD-L1 positive and pathologically confirmed as Stage N3. Enrolled patients will be randomly assigned to receive either standard adjuvant SOX regimen or SOX regimen combined with sintilimab. The objective of the study is to determine whether adding a PD-1 inhibitor to postoperative chemotherapy can improve the Disease-Free Survival (DFS) rate in patients with Stage N3 gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sintilimab + SOX | Active comparator | Drug: Sintilimab, Drug: SOX ChemotherapyPatients will first receive 6 to 8 cycles of treatment with sintilimab + SOX; sintilimab will subsequently be continued as maintenance therapy for up to one year. |
| SOX | Active comparator | Drug: SOX ChemotherapyPatients will receive 6 to 8 cycles of treatment with SOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Sign a written informed consent form prior to the initiation of any study-related procedures.
- Aged between 18 and 75 years.
- Have undergone radical resection with D2 or wider lymph node dissection and achieved R0 resection status.
- No prior systemic anti-tumor treatment (i.e., neoadjuvant therapy) before surgery.
- Histopathologically confirmed gastric adenocarcinoma.
Key exclusion criteria (26 listed)
- Pathologically confirmed as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, neuroendocrine tumor, or gastrointestinal stromal tumor (mixed carcinoma with adenocarcinoma component > 80% is eligible for enrollment).
- Diagnosis of malignant diseases other than gastric cancer within 5 years before the first dose administration (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, differentiated thyroid cancer, and/or radically resected carcinoma in situ).
- Currently participating in therapeutic clinical research, or having received other study drugs within 4 weeks before the first dose administration.
- Previous receipt of the following therapies: anti-PD-1, anti-PD-L1, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.).
- Receipt of Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) via systemic treatment within 2 weeks before the first dose administration.
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 |
|---|---|---|
| SintilimabFor patients with body weight < 60 kg, the dose is 3 mg/kg, administered via intravenous infusion (i.v.gtt.) on Day 1; for patients with body weight ≥ 60 kg, a fixed dose of 200 mg is administered via intravenous infusion (i.v.gtt.) on Day 1. The treatment is repeated every 21 days. | Drug | Sintilimab + SOX |
| SOX ChemotherapyS-1: 40 mg/m², oral administration (p.o.), twice daily (b.i.d.), on Days 1 to 14; repeated every 21 days. Oxaliplatin: 130 mg/m², intravenous infusion (i.v.gtt.), on Day 1; repeated every 21 days. | Drug | SOX, Sintilimab + SOX |
Primary outcome
Disease-Free Survival (DFS)
Time frame: 3 years
Defined from the date of completion of curative-intent treatment (e.g., surgery, adjuvant chemotherapy) to the date of first documentation of disease recurrence (e.g., tumor relapse, metastasis) or death from any cause, whichever occurs first.
3 secondary outcomes
Overall Survival (OS)
Time frame: 5 years
Incidence rate of adverse events (AEs)
Time frame: 3 years
Serious adverse events (SAE)
Time frame: 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 4 Dec 2025.
Related trials for Gastric Adenocarcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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 Sintilimab and SOX Chemotherapy 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 19 inclusion and 26 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 4 Dec 2025. 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 Hao Xu, M.D & Ph.D (025-68306505, Hxu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) (time frame: 3 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 4 Dec 2025.