Immunotherapy Gastrict Cancer
Conditions
Brief summary
To evaluate the clinical efficacy and safety of Tislelizumab combined with apatinib mesylate, oxaliplatin plus S1 Vs oxaliplatin plus S1.
Interventions
DRUGTislelizumab
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 4 cycles. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.
DRUGapatinib
Participants will receive apatinib, 250mg, qd，every 3 weeks for 3 weeks
DRUGoxaliplatin
Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 4 weeks.
DRUGS-1
Participants will receive S-1, day 1-14 of every 3 weeks for 4 weeks.
Sponsors
Fujian Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-70 years of age. * Histologically confirmed gastric adenocarcinoma was diagnosed in patients with locally advanced gastric cancer with tumor volume \>5cm Borrmann III, Borrmann IV and BulkyN according to AJCC Version 8. * Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1. * ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores. * No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed. * Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells. * The expected survival time is more than 6 months. * For women of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested.Women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.
Exclusion criteria
* Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ). * Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed，if it was still positive after reexamination, gastroscopy was required. * Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137). * A history of immunodeficiency, including HIV testing positive. * Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing. * Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally. * HER2 positive is known. * Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response | 4 weeks after surgery | Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response | 4 weeks after surgery | Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell |
| Objective Response Rate (ORR) | At the end of Cycle 3 (each cycle is 21 days)] | Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor |
Countries
China
Contacts
Primary Contactchen lu chuan, bachelor
Backup ContactYe Z sheng, Doctor of Medicine
Outcome results
None listed