Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2ALTER-SOXNCT07772557
Adjuvant Therapy for Potentially Immunotherapy-Responsive Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg pe and Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, i in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
This study evaluates the clinical efficacy and safety benefits of immunotherapy in a selected patient population by comparing serplulimab combined with short-course SOX regimen versus SOX regimen alone as adjuvant therapy for patients with stage pII-III gastric or gastroesophageal junction (G/EGJ) adenocarcinoma who… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg pe and Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, i
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 20 Jan 2032
- 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
- The patient voluntarily joins this study and signs the informed consent form.
- Age ≥18 years and ≤75 years, male or female.
- Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma (predominantly adenocarcinoma) with stage II-III disease (TNM staging, 8th UICC/AJCC) who have not received preoperative neoadjuvant therapy.
- ECOG performance status: 0-1.
- Postoperative testing of gastric cancer specimens indicates: PD-L1 CPS ≥5, or EBV-positive, or dMMR.
- No prior anti-tumor therapy for gastric cancer, including chemotherapy, targeted therapy, immunotherapy, or local radiotherapy.
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- Female patients of childbearing potential (not surgically sterilized) must use a medically acceptable contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months after the end of the study treatment. Female patients of childbearing potential must have a negative serum or urine HCG test within 72 hours prior to study enrollment and must not be breastfeeding. Male patients must be surgically sterilized or agree to use an appropriate contraceptive method during the study period and for 3 months after the last dose of the investigational drug.
- Baseline hematological and biochemical parameters must meet the following criteria:
- Hemoglobin ≥90 g/L; Absolute neutrophil count ≥1.5×10⁹/L; Platelet count ≥100×10⁹/L; Hepatic function: ALT ≤2.5×ULN, AST ≤2.5×ULN, TBIL ≤1.5×ULN (for patients with liver metastases: ALT ≤5×ULN, AST ≤5×ULN, TBIL ≤3×ULN); Renal function: Creatinine ≤1.5×ULN, or when creatinine >1.5×ULN, endogenous creatinine clearance >50 mL/min; Alkaline phosphatase ≤2.5×ULN; Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, T3 and T4 levels should be evaluated; patients may be enrolled if T3 and T4 levels are within normal limits).
Who cannot join
- The patient voluntarily joins this study and signs the informed consent form. (Note: This item appears to be an inclusion criterion and is likely misplaced. Please verify.)
- Pregnant or breastfeeding women.
- Women of childbearing potential with a positive baseline pregnancy test.
- Distant metastasis diagnosed by CT/MRI/EUS.
- Prior anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
- Diagnosis of another malignancy within the past 5 years (excluding basal cell or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix, or breast cancer).
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- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Severe cardiovascular disease within 12 months prior to enrollment, such as symptomatic coronary artery disease, congestive heart failure ≥ Class II, uncontrolled arrhythmia, or myocardial infarction.
- Concurrent upper gastrointestinal obstruction/bleeding, or digestive dysfunction/malabsorption syndrome that may affect the absorption of S-1.
- Concurrent severe uncontrolled infection or other severe uncontrolled concomitant disease, moderate or severe renal impairment.
- History of allergic reactions to any of the study drugs.
- Use of corticosteroids or other systemic immunosuppressive therapy within 14 days prior to enrollment.
- Receipt of an investigational drug within 4 weeks prior to enrollment (participation in another clinical trial).
- Active autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator therapy). Subjects with hypothyroidism requiring only hormone replacement therapy, or skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), may be enrolled.
- History of primary immunodeficiency.
- Use of immunosuppressive agents within 4 weeks prior to the first dose of study treatment, excluding nasal sprays, inhaled, or other topical corticosteroids, or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/day of prednisone or equivalent), or prophylactic use of corticosteroids for contrast allergy.
- Receipt of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment, or planned receipt during the study period.
- Known interstitial pneumonia or active pulmonary tuberculosis.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Positive HIV antibody, active hepatitis B or hepatitis C (hepatitis B: HBsAg positive and HBV-DNA ≥10⁴ copies/mL; hepatitis C: HCV antibody and HCV-RNA positive, requiring concurrent antiviral therapy).
- Other factors that, in the investigator's judgment, may affect subject safety or trial compliance, such as severe concomitant disease requiring treatment (including psychiatric disorders), severe laboratory abnormalities, or other family or social factors.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Serplulimab Combined With Short-Course SOX Regimen Versus SOX Regimen Alone as Adjuvant Therapy for Potentially Immunotherapy-Responsive Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Randomized Controlled Trial
This study evaluates the clinical efficacy and safety benefits of immunotherapy in a selected patient population by comparing serplulimab combined with short-course SOX regimen versus SOX regimen alone as adjuvant therapy for patients with stage pII-III gastric or gastroesophageal junction (G/EGJ) adenocarcinoma who are PD-L1 CPS ≥5, EBV-positive, or dMMR/MSI-H.
- Being tested
- Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg pe, Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, i
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg peDrug
SOX
Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, iDrug
Serplulimab+SOX
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment Group | Active comparator | Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg per dose for BSA ≥ 1.25 to < 1.5, 60 mg per dose for BSA ≥ 1.5, twice daily, administered from D1 to D14 of each cycle, Q3W, for up to 6 cycles postoperatively. Receives: Drug: Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg pe |
| Experimental Immunotherapy Group | Experimental | Experimental Immunotherapy Group:
Phase I: Combination Therapy Period (First 3 Cycles)
Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles.
Serplulimab: 300 mg, intravenous infusion, Day 1, every 3 weeks (Q3W), administered concurrently with oxaliplatin.
S-1 (Tegafur-Gimeracil-Oteracil Potassium): Same administration regimen as the control group (oral, D1-D14, Q3W), for 3 cycles.
Phase II: Immunotherapy Maintenance Period (From Cycle 4 Onward)
Serplulimab: 300 mg, intravenous infusion, Day 1, every 3 weeks (Q3W), continued until 1 year post-surgery or until radiographic confirmation of tumor recurrence or metastasis. Receives: Drug: Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, i |
What is being measured
The primary outcome is the main question the study is designed to answer.
3yr-RFS rate
Defined as the proportion of patients who have not developed local or regional recurrence or distant metastasis from randomization to the 3-year follow-up, excluding second primary malignancies and non-tumor-related deaths.
Measured: from randomization to the 3-year follow-up
Secondary outcomes (3)
Recurrence-Free Survival (RFS)
Defined as the time from randomization to the occurrence of local or regional recurrence or distant metastasis, excluding second primary malignancies and non-tumor-related deaths. If a patient does not experience disease progression during the study period, RFS is defined as the time to the last date on which the patient was confirmed to be progression-free.
Measured: from randomization until the date of first documented occurrence of local or regional recurrence or distant metastasis, whichever came first,Up to 5 years
Overall Survival (OS)
Overall survival is defined as the time from patient enrollment to death from any cause. For patients who are still alive at the last follow-up, OS is censored at the date of last follow-up. For patients lost to follow-up, OS is censored at the last date on which the patient was confirmed to be alive prior to loss to follow-up. Censored OS is defined as the time from enrollment to censoring.
Measured: From date of randomization until the date of first documented date of death from any cause，Up to 5 years.
Safety
All adverse events occurring in patients during the clinical study period will be monitored, including clinical symptoms, abnormal vital signs, and laboratory test abnormalities. The clinical characteristics, severity, time of onset, duration, management, and outcome of each adverse event will be recorded, and the causal relationship with the investigational drug will be assessed. Drug safety will be evaluated using the NCI-CTCAE Version 5.0 criteria.
Measured: All subjects should continue to undergo safety assessments and adverse event follow-up for 90 days after the last dose, and concomitant treatments should be recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion20 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric or Gastroesophageal Junction 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
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Xu, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772557
- Sponsor's protocol ID
- 2026-SR-531
- Acronym
- ALTER-SOX
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Serplulimab Combined With Short-Course SOX Regimen Versus SOX Regimen Alone as Adjuvant Therapy for Potentially Immunotherapy-Responsive Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07772557
- Acronym / sponsor ID
- ALTER-SOX / 2026-SR-531
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 20 Jan 2032 (estimated)
- First posted
- 19 Aug 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 evaluates the clinical efficacy and safety benefits of immunotherapy in a selected patient population by comparing serplulimab combined with short-course SOX regimen versus SOX regimen alone as adjuvant therapy for patients with stage pII-III gastric or gastroesophageal junction (G/EGJ) adenocarcinoma who are PD-L1 CPS ≥5, EBV-positive, or dMMR/MSI-H.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment Group | Active comparator | Drug: Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg peStandard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg per dose for BSA ≥ 1.25 to < 1.5, 60 mg per dose for BSA ≥ 1.5, twice daily, administered from D1 to D14 of each cycle, Q3W, for up to 6 cycles postoperatively. |
| Experimental Immunotherapy Group | Experimental | Drug: Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, iExperimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, intravenous infusion, Day 1, every 3 weeks (Q3W), administered concurrently with oxaliplatin. S-1 (Tegafur-Gimeracil-Oteracil Potassium): Same administration regimen as the control group (oral, D1-D14, Q3W), for 3 cycles. Phase II: Immunotherapy Maintenance Period (From Cycle 4 Onward) Serplulimab: 300 mg, intravenous infusion, Day 1, every 3 weeks (Q3W), continued until 1 year post-surgery or until radiographic confirmation of tumor recurrence or metastasis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient voluntarily joins this study and signs the informed consent form.
- Age ≥18 years and ≤75 years, male or female.
- Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma (predominantly adenocarcinoma) with stage II-III disease (TNM staging, 8th UICC/AJCC) who have not received preoperative neoadjuvant therapy.
- ECOG performance status: 0-1.
- Postoperative testing of gastric cancer specimens indicates: PD-L1 CPS ≥5, or EBV-positive, or dMMR.
Key exclusion criteria (21 listed)
- The patient voluntarily joins this study and signs the informed consent form. (Note: This item appears to be an inclusion criterion and is likely misplaced. Please verify.)
- Pregnant or breastfeeding women.
- Women of childbearing potential with a positive baseline pregnancy test.
- Distant metastasis diagnosed by CT/MRI/EUS.
- Prior anti-tumor therapy, including chemotherapy, radiotherapy, or immunotherapy.
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 |
|---|---|---|
| Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg peSOX | Drug | Standard Treatment Group |
| Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, iSerplulimab+SOX | Drug | Experimental Immunotherapy Group |
Primary outcome
3yr-RFS rate
Time frame: from randomization to the 3-year follow-up
Defined as the proportion of patients who have not developed local or regional recurrence or distant metastasis from randomization to the 3-year follow-up, excluding second primary malignancies and non-tumor-related deaths.
3 secondary outcomes
Recurrence-Free Survival (RFS)
Time frame: from randomization until the date of first documented occurrence of local or regional recurrence or distant metastasis, whichever came first,Up to 5 years
Overall Survival (OS)
Time frame: From date of randomization until the date of first documented date of death from any cause，Up to 5 years.
Safety
Time frame: All subjects should continue to undergo safety assessments and adverse event follow-up for 90 days after the last dose, and concomitant treatments should be recorded.
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 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg pe and Experimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, i in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by The First Affiliated Hospital with Nanjing Medical University.
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 9 inclusion and 21 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: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (86-2568306505, liuhongda@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3yr-RFS rate (time frame: from randomization to the 3-year follow-up). 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 19 Aug 2026.