A Phase 2 interventional study of Ferrous succinate and Ferrous Sulfate in Gastric Neoplasms, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 2, Interventional, and Treatment
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.
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 54 is below the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 172 studies on the registry; 136 are open to participants now.
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Exclusion Criteria:
Patients receive serplulimab combined with SOX regimen, together with oral ferrous succinate.
Drug: Ferrous succinate · Drug: Serplulimab
Patients receive serplulimab combined with SOX regimen, together with oral ferrous sulfate.
Drug: Ferrous Sulfate · Drug: Serplulimab
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.
Also known as: Oxaliplatin, Tegafur
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.
Also known as: Oxaliplatin, Tegafur
Serplulimab
Pathological complete response (pCR) rate
Proportion of patients achieving pathological complete response (no viable tumor cells in resected specimen) after 3 cycles of neoadjuvant therapy
Time frame: Within 4 weeks after surgery (approximately 12 weeks after treatment initiation)
1-year event-free survival (EFS) and 2-year EFS
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.
Time frame: Up to 24 months after treatment initiation
Objective response rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR), assessed per RECIST version 1.1.
Time frame: After completion of neoadjuvant therapy (approximately 12 weeks after treatment initiation)
R0 resection rate
Proportion of patients who undergo curative surgery and achieve R0 resection (microscopically negative resection margins).
Time frame: At the time of surgical resection (approximately 12-16 weeks after treatment initiation)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ferrous succinate · Ferrous sulfate
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →