Actively Recruiting
Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-07-11
35
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
evaluate efficacy and safety of neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer
CONDITIONS
Official Title
Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Clinical stage T3-4aN+M0 diagnosed by ultrasound endoscopy or enhanced CT/MRI
- Male or female aged 18 to 75 years
- Tumor considered resectable by study surgeons
- ECOG performance status 0 to 1
- Good physical condition and adequate organ function for abdominal surgery
- Adequate blood counts: neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L
- Adequate liver function: total bilirubin ≤ 1.5 × ULN; AST and ALT < 2.5 × ULN; ALP ≤ 2.5 × ULN; albumin ≥ 30 g/L
- Adequate kidney function: serum creatinine ≤ 1.5 × ULN, creatinine clearance ≥ 60 ml/min
- Adequate coagulation: INR/PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN
- No serious coexisting diseases threatening survival less than 5 years
- Signed informed consent
- Willingness to comply with study procedures and treatments
- Female participants must not be pregnant or breastfeeding
- PD-L1 assessment performed
You will not qualify if you...
- Distant metastasis or unresectable primary tumor
- Tumor stage T1 or T2 by imaging
- Prior chemotherapy, radiation, immunotherapy, or radical surgery for gastric cancer
- Active or refractory autoimmune disease
- Active malignancy in past 2 years except certain cured local tumors
- Uncontrolled pleural, pericardial effusion, or ascites within 2 weeks
- Digestive tract bleeding or high bleeding risk within 2 weeks
- Gastrointestinal perforation or fistula within 6 months
- Upper GI obstruction, malabsorption syndrome affecting S-1 absorption
- Weight loss over 20% in past 2 months
- History of interstitial lung disease, pneumonitis, fibrosis, or acute lung disease
- Uncontrolled systemic diseases such as diabetes or hypertension
- Severe or active infections requiring systemic treatment including TB or HIV
- Untreated chronic hepatitis B or high viral load, or positive hepatitis C RNA
- Cardiovascular risks including recent chest pain, pulmonary embolism, myocardial infarction, heart failure, arrhythmias, or stroke within specified timeframes
- Peripheral neuropathy grade 1 or higher except loss of deep tendon reflex
- Moderate or severe kidney injury
- Dipyrimidine dehydrogenase deficiency
- Allergy to study drugs
- History of stem cell or organ transplantation
- Recent use of steroids or systemic immunosuppressive therapy beyond allowed exceptions
- Live vaccine within 4 weeks
- Immune therapy or trial treatments within 28 days
- Palliative radiation within 14 days
- Prior treatment with PD-1, PD-L1, PD-L2, or related checkpoint inhibitors
- Surgery within 28 days except minor procedures
- Uncontrolled epilepsy, CNS diseases, or mental disorders affecting consent or compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
H
hongjie zhan
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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