Actively Recruiting
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
Led by Zekuan Xu · Updated on 2026-03-03
30
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.
CONDITIONS
Official Title
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of gastric or gastroesophageal junction adenocarcinoma confirmed by pathology
- Clinical stage III disease assessed by imaging (cT3-4aN1-3M0)
- Tumor classified as HER2-negative
- Siewert type II (without need for thoracic surgery) or type III GEJ cancer
- Tumors deemed resectable with curative intent by surgeon and radiologist
- Agreement to undergo radical surgery and operability confirmed by surgeon
- No prior systemic treatment for current disease
- Expected survival of at least 3 months
- Measurable tumor according to RECIST v1.1
- ECOG performance status 0-1 within 7 days before first dose
- Good cardiac function suitable for surgery
- Normal organ function meeting specific laboratory criteria (blood counts, liver, kidney, coagulation, thyroid, myocardial enzymes)
- Body weight ≥ 40 kg or BMI > 18.5
- Female participants must be post-menopausal, surgically sterilized, or have a negative pregnancy test within 7 days before first dose
- Agreement to use effective contraception or abstain from heterosexual intercourse during and after study as specified
- Male participants must agree to use contraception or abstain from heterosexual intercourse during and after study as specified
- Ability to understand and sign informed consent
You will not qualify if you...
- History of other malignancies within past 5 years except certain cured localized tumors
- Planned or previous organ or bone marrow transplant
- Blood transfusion within 2 weeks before first dose
- History of severe bleeding events within 4 weeks before screening
- Coagulation disorders with INR > 1.5 without anticoagulants
- Arterial or venous thromboembolic events within 6 months before screening
- Myocardial infarction or uncontrolled arrhythmias within 6 months before first dose
- NYHA class III-IV heart failure or LVEF < 50%
- Significant proteinuria
- Conditions affecting oral drug absorption
- Clinically significant pleural or peritoneal effusion
- HIV infection
- Active tuberculosis
- Non-healing wounds or incomplete fracture healing
- Lung diseases affecting detection or treatment of drug-related toxicity
- Active or suspected autoimmune diseases requiring systemic immunosuppression
- Severe chronic autoimmune diseases or certain histories of autoimmune conditions
- Use of systemic corticosteroids >10 mg/day prednisone equivalent or other immunosuppressants within 14 days before first dose
- Active infections needing systemic treatment within 14 days before first dose
- Live vaccines within 28 days before first dose
- Previous treatment with checkpoint inhibitors
- Immunomodulatory treatments within 6 months before first dose
- Participation in other clinical studies with overlapping treatments
- Known allergy or intolerance to study drugs
- History of substance abuse
- Non-compliance with medical instructions affecting assessments
- Pregnant or breastfeeding women
- Conditions increasing study risks or deemed unsuitable by investigator
- Any other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
H
Hao Xu, MD
CONTACT
H
Hongda Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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