Status:
RECRUITING
Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen
Lead Sponsor:
Shanghai Minimally Invasive Surgery Center
Conditions:
Gastric Cancer Stage IIIB-IIIC
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer
Eligibility Criteria
Inclusion
- 1\. Subjects voluntarily join the study and sign an informed consent form; 2. Male or female patients between the ages of 18-75; 3. Adenocarcinoma of the gastric/esophagogastric junction after radical resection was staged at stage IIIB-IIIC; 4. The molecular pathology of gastric cancer must meet at least one of the following three conditions:
- Consistent with high-frequency microsatellite instability MSI-H
- Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases)
- High expression of PD-L1 (CPS score ≥5) 5. Expected survival time \> 6 months； 6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points; 7. Have not received anti-tumor immunotherapy; 8. Agree to provide archived tumor tissue samples for molecular testing; 9. Have good organ function:
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- Hemoglobin ≥90g/L;
- Absolute neutrophil count ≥1.5×109/ L;
- Platelet count ≥100×109/ L;
- aspartate or alanine aminotransferase ≤ 2.5 times the upper limit;
- alkaline phosphatase ≤ 2.5 times the upper normal limit ; 10. Women of reproductive age who need to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period; For men who agreed to use an appropriate method of contraception during the trial and for 3 months after the last dose of the trial drug.
- 11\. Women of reproductive age must be negative for serum or urine HCG within 72 hours prior to study entry. And must be non-lactating.
Exclusion
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- Patients with severe hypertension and poor drug control;
- Patients with difficulty in taking oral drugs due to dysphagia, complete or incomplete digestive tract obstruction, active gastrointestinal bleeding, perforation, etc.;
- People who are known to be allergic to the ingredients in the test drug or have metabolic disorders;
- Simultaneously participating in other tumor experimental drugs or being in other tumor clinical trials.
- Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrollable diabetes, hypertension and other chronic system diseases; Clinically obvious heart disease, such as congestive heart failure, obvious coronary heart disease, medically difficult to control arrhythmia, hypertension, or myocardial infarction within 6 months, or cardiac insufficiency;
- Patients with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders;
- Diagnosed with immunodeficiency or received systemic hormone therapy or other forms of immunosuppressive therapy within 7 days prior to initial administration;
- Active period \> CTCAE (Version 5.0) grade 2 clinical severe infection;
- Pregnant and lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods;
- Persons without legal capacity, whose medical or ethical reasons affect the continuation of the research.
- Other conditions determined by the investigator to be unsuitable for inclusion in the study.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06036745
Start Date
July 1 2022
End Date
July 1 2026
Last Update
March 7 2024
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025