Gastric Neoplasms
Conditions
Brief summary
Patients with locally advanced gastric cancer have a high risk of postoperative recurrence. Neoadjuvant chemotherapy can improve the R0 resection rate, but some patients gain limited benefit from conventional chemotherapy. The PD-1 monoclonal antibody serplulimab combined with chemotherapy has shown potential in improving response rate and survival for advanced gastric cancer. Regulation of tumor metabolism and immune microenvironment may further enhance the efficacy of immunotherapy. Ferrous sulfate supplementation improves anemia and immune cell metabolism; succinate, as a key metabolic signaling molecule, participates in inflammation and immune regulation. This study intends to explore the synergistic effect and safety of oral ferrous sulfate/ferrous succinate in serplulimab plus SOX neoadjuvant therapy.
Interventions
Patients receive serplulimab 200mg iv drip Q3W, oxaliplatin 130mg/m² iv gtt d1, S-1 40-60mg bid po d1-14. Rest for 1 week per cycle, total 3 cycles. Ferrous succinate 200mg bid po d1-d21 is given concurrently.
DRUGFerrous Sulfate
Patients receive serplulimab 200mg iv drip Q3W, oxaliplatin 130mg/m² iv gtt d1, S-1 40-60mg bid po d1-14. Rest for 1 week per cycle, total 3 cycles. Ferrous sulfate 200mg bid po d1-d21 is given concurrently.
DRUGSerplulimab
Serplulimab
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
* Histologically confirmed gastric adenocarcinoma * Clinically diagnosed as locally advanced gastric cancer (cT2-4aNanyM0) * Age 18-75 years, male or female * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ and hematologic function: * Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L * Platelets ≥ 100 × 10\^9/L * Hemoglobin ≥ 90 g/L * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN * Creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 50 mL/min * Measurable lesion according to RECIST version 1.1 * No prior anti-cancer therapy for the current gastric cancer * Willing and able to provide written informed consent
Exclusion criteria
* Histologically confirmed gastric squamous cell carcinoma, adenosquamous carcinoma, or neuroendocrine carcinoma * Distant metastasis (M1) or unresectable disease * History of other malignancies within the past 5 years (except adequately treated non-melanoma skin cancer or in situ cervical cancer) * Prior treatment with PD-1/PD-L1 inhibitors, iron supplementation, or chemotherapy for gastric cancer * Known hypersensitivity to any study drug components * Active or uncontrolled autoimmune disease * Severe cardiovascular disease (New York Heart Association class III-IV) or myocardial infarction within 6 months * Active infection requiring systemic anti-infective therapy * Pregnancy or breastfeeding women * Inability to comply with study procedures or follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) rate | Within 4 weeks after surgery (approximately 12 weeks after treatment initiation) | Proportion of patients achieving pathological complete response (no viable tumor cells in resected specimen) after 3 cycles of neoadjuvant therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year event-free survival (EFS) and 2-year EFS | Up to 24 months after treatment initiation | Event-free survival (EFS) is defined as the time from treatment initiation to the first occurrence of disease progression, recurrence, death from any cause, or loss to follow-up. 1-year EFS and 2-year EFS will be evaluated. |
| Objective response rate (ORR) | After completion of neoadjuvant therapy (approximately 12 weeks after treatment initiation) | Proportion of patients achieving complete response (CR) or partial response (PR), assessed per RECIST version 1.1. |
| R0 resection rate | At the time of surgical resection (approximately 12-16 weeks after treatment initiation) | Proportion of patients who undergo curative surgery and achieve R0 resection (microscopically negative resection margins). |
Countries
China
Contacts
CONTACTkaixiong Tao, MD
Outcome results
None listed