Actively Recruiting
The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2023-03-09
38
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a signle-arm, multi-center, open-lable, phase II study. The objective is to evaluate the effectiveness and safety of tislelizumab + oxaliplatin + capecitabine + PLD in the neoadjuvant treatment of resectable gastric adenocarcinoma.
CONDITIONS
Official Title
The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Karnofsky Performance Status Score of 70 or higher
- Histologically or cytologically confirmed gastric adenocarcinoma that is HER2-negative and PD-1/L1 positive
- Clinical stage III gastric cancer according to the 8th edition of the AJCC Cancer Staging Manual
- Physical condition and organ function suitable for major abdominal surgery
- Baseline blood tests meeting minimum standards for hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, creatinine, and albumin
- Heart function with left ventricular ejection fraction 50% or higher, no myocardial ischemia on ECG, and no arrhythmia requiring medication prior to enrollment
- No serious diseases expected to limit survival to less than 5 years
- Ability and willingness to comply with study protocol
- Signed written informed consent
You will not qualify if you...
- Prior chemotherapy, radiotherapy, or immunotherapy for gastric cancer
- Pregnant or breastfeeding women
- Women of childbearing potential with positive or missing pregnancy test; menopausal women must have been menopausal for at least 12 months
- Men and women who are sexually active and unwilling to use contraception during the study
- Presence of mass ascites or positive abdominal free cancer cells
- History of other malignancies within 5 years, except cured non-melanoma skin cancer or cervical carcinoma in situ
- History of epilepsy, central nervous system disease, or mental disorders that may affect consent or medication compliance
- Severe active heart disease including symptomatic coronary disease, NYHA class II or above heart failure, severe arrhythmia, or recent myocardial infarction within 12 months
- Deficiency of dihydropyrimidine dehydrogenase (DPD)
- Peripheral nerve disease grade 2 or higher (except isolated loss of deep tendon reflexes)
- Organ transplantation requiring immunosuppressive therapy
- Severe uncontrolled infections or other serious uncontrolled diseases
- Moderate or severe kidney damage defined by creatinine clearance ≤50 ml/min or elevated serum creatinine
- Active hepatitis B or C infection with specified viral loads or positive hepatitis B surface antigen
- Allergy to any study drug ingredients
- Participation in other clinical trials within 4 weeks prior to enrollment
- Any condition judged by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, China, 200080
Actively Recruiting
Research Team
Q
Qi Li, Prof.
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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