Actively Recruiting
Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen
Led by Shanghai Minimally Invasive Surgery Center · Updated on 2024-03-07
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female aged 18 to 75 years
- Diagnosed with adenocarcinoma of the gastric or esophagogastric junction at stage IIIB or IIIC after radical surgery
- Molecular pathology shows at least one: high-frequency microsatellite instability (MSI-H), high tumor mutation burden (≥10 mutations/megabases), or PD-L1 expression (CPS score ≥5)
- Expected survival time greater than 6 months
- ECOG performance status score of 0 or 1
- No prior anti-tumor immunotherapy
- Agree to provide archived tumor tissue for molecular testing
- Adequate organ function including hemoglobin ≥90 g/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, liver enzymes and alkaline phosphatase ≤2.5 times upper normal limit
- Women of reproductive age must use medically approved contraception during and for 3 months after treatment; men must use contraception during treatment and for 3 months after last dose
- Women of reproductive age must have a negative pregnancy test within 72 hours before study entry and not be breastfeeding
You will not qualify if you...
- Severe hypertension not controlled by medication
- Difficulty taking oral drugs due to swallowing problems, digestive obstruction, active bleeding, or perforation
- Known allergy to any study drug ingredients or metabolic disorders
- Currently enrolled in other tumor drug trials or experimental treatments
- Severe chronic diseases including liver cirrhosis, kidney disease, respiratory disease, uncontrolled diabetes or hypertension, or serious heart disease such as recent myocardial infarction or heart failure
- Peripheral nervous system disorders, mental disorders, or central nervous system disorders
- Diagnosed immunodeficiency or received systemic hormone or immunosuppressive therapy within 7 days before starting treatment
- Active severe infection above CTCAE grade 2
- Pregnant or breastfeeding women, or those and their partners refusing effective contraception
- Lack of legal capacity or medical/ethical reasons making study continuation unsuitable
- Any other condition the investigator deems unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
Z
Zhenghao Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here