Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions
Brief 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 are PD-L1 CPS ≥5, EBV-positive, or dMMR/MSI-H.
Interventions
DRUGStandard 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
SOX
DRUGExperimental 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
Serplulimab+SOX
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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).
Exclusion criteria
* 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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3yr-RFS rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From date of randomization until the date of first documented date of death from any cause，Up to 5 years. | 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. |
| Recurrence-Free Survival (RFS) | from randomization until the date of first documented occurrence of local or regional recurrence or distant metastasis, whichever came first,Up to 5 years | 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. |
| Safety | 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. | 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. |
Contacts
CONTACTHao XU
Outcome results
None listed