Gastric NeoplasmsPhase 2NCT07872696
Exploring the Efficacy of Ferrous Sulfate/Ferrous Succinate Combined With Serplulimab and SOX Regimen in Neoadjuvant Therapy for Gastric Cancer: A Prospective Cohort Study
A Phase 2 study testing Ferrous succinate, Ferrous Sulfate and Serplulimab in people with Gastric Neoplasms, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Neoplasms
- What is being tested?
- Ferrous succinate, Ferrous Sulfate and Serplulimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Sep 2029
- 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
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
kaixiong Tao, MD, 86-13507155452, tao_kaixiong@163.com
About this study
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.
- Conditions
- Gastric Neoplasms
- Being tested
- Ferrous succinate, Ferrous Sulfate, Serplulimab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous succinateDrug
Also called 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 succinate 200mg bid po d1-d21 is given concurrently.
Ferrous SulfateDrug
Also called 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.
SerplulimabDrug
Serplulimab
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab + SOX plus oral ferrous succinate | Experimental | Patients receive serplulimab combined with SOX regimen, together with oral ferrous succinate. Receives: Drug: Ferrous succinate; Drug: Serplulimab |
| Serplulimab + SOX plus oral ferrous sulfate | Experimental | Patients receive serplulimab combined with SOX regimen, together with oral ferrous sulfate. Receives: Drug: Ferrous Sulfate; Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 4 weeks after surgery (approximately 12 weeks after treatment initiation)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: At the time of surgical resection (approximately 12-16 weeks after treatment initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric NeoplasmsStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 54 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872696
- Sponsor's protocol ID
- 0427
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Efficacy of Ferrous Sulfate/Ferrous Succinate Combined With Serplulimab and SOX Regimen in Neoadjuvant Therapy for Gastric Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07872696
- Acronym / sponsor ID
- 0427
- Conditions
- Gastric Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 14 Oct 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serplulimab + SOX plus oral ferrous succinate | Experimental | Drug: Ferrous succinate, Drug: SerplulimabPatients receive serplulimab combined with SOX regimen, together with oral ferrous succinate. |
| Serplulimab + SOX plus oral ferrous sulfate | Experimental | Drug: Ferrous Sulfate, Drug: SerplulimabPatients receive serplulimab combined with SOX regimen, together with oral ferrous sulfate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Ferrous succinateAlso: Oxaliplatin, TegafurPatients 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. | Drug | Serplulimab + SOX plus oral ferrous succinate |
| Ferrous SulfateAlso: Oxaliplatin, TegafurPatients 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. | Drug | Serplulimab + SOX plus oral ferrous sulfate |
| SerplulimabSerplulimab | Drug | Serplulimab + SOX plus oral ferrous succinate, Serplulimab + SOX plus oral ferrous sulfate |
Primary outcome
Pathological complete response (pCR) rate
Time frame: 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
3 secondary outcomes
1-year event-free survival (EFS) and 2-year EFS
Time frame: Up to 24 months after treatment initiation
Objective response rate (ORR)
Time frame: After completion of neoadjuvant therapy (approximately 12 weeks after treatment initiation)
R0 resection rate
Time frame: At the time of surgical resection (approximately 12-16 weeks after treatment initiation)
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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferrous succinate, Ferrous Sulfate and Serplulimab in people with Gastric Neoplasms, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 14 inclusion and 10 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 kaixiong Tao, MD (86-13507155452, tao_kaixiong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: Within 4 weeks after surgery (approximately 12 weeks after treatment initiation)). 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 14 Oct 2026.