NCT07872696Not yet recruitingPhase 2
Exploring the Efficacy of Ferrous Sulfate/Ferrous Succinate Combined With Serplulimab and SOX Regimen in Neoadjuvant Therapy for Gastric Cancer: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 22 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07872696
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 54
- From Sept 2026 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with PD-1/PD-L1 inhibitors, iron supplementation, or chemotherapy for gastric cancer
Other illness
- 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)
- 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
Other
- Histologically confirmed gastric squamous cell carcinoma, adenosquamous carcinoma, or neuroendocrine carcinoma
- Pregnancy or breastfeeding women
- Inability to comply with study procedures or follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.