A Single-arm, Open-label, Multicenter Phase 2 Study to Evaluate XELOX + Tislelizumab in Combination With Doxorubicin Hydrochloride Liposome Injection （XELOX+PD-1+PLD）as Neoadjuvant Therapy for Resectable Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- PLD
- Conditions
- Gastric Cancer
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Pathological complete remission rate
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
This single-arm, multicenter, open-label study plan to enroll patients with resectable stage III gastric adenocarcinoma to recieve tislelizumab + oxaliplatin + capecitabine + PLD regimen for 2 or 4 cycles, radical resection will be performed after neoadjuvant therapy. Radiological evaluation will be performed every 2 cycles to evaluate the resectability of tumor. Survival follow-up will be performed after surgery, until patient's withdrawal of informed consent, loss to follow-up or death, whichever comes first.
Investigators
Qi Li
Chief Physician
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Age: 18\~75 years old.
- •Karnofsky Performance Status Score ≥
- •Histological or cytological diagnosed as gastric adenocarcinoma, HER2-, PD-1/L1+.
- •Clinical stage stage III (8th edition of the AJCC Cancer Staging Manual).
- •Physical condition and organ function allow for larger abdominal surgery.
- •Subject baseline blood routine and biochemical indicators meet the following standards: hemoglobin ≥90g/L; absolute neutrophil count (ANC) ≥1.5×10\^9g/L; platelets counts (PLT) ≥100×10\^9/L; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN); serum total bilirubin \<1.5 ULN; serum creatinine \<1 ULN; serum albumin ≥30g/L.
- •Heart function:
- •Left ventricular ejection fraction (LVEF) ≥50%;
- •12-ECG indicates no myocardial ischemia;
- •No history of arrhythmia requiring drug intervention before enrollment;
Exclusion Criteria
- •Received chemotherapy, radiotherapy or immunotherapy for this gastric cancer.
- •Pregnant or breastfeeding women.
- •Women of childbearing age who had a positive pregnancy test at baseline or who did not have a pregnancy test. Menopausal women must have menopause for at least 12 months before they can become pregnant.
- •Men and women who are sexually active (possible to have children) are unwilling to use contraception during the study period.
- •Patients with mass ascites and positive abdominal free cancer cells.
- •With a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ.
- •With a history of epilepsy, central nervous system disease, or mental disorder may be judged by the investigator that their clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- •Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring medical intervention, or the last 12 There was a history of myocardial infarction within months.
- •Patients deficiency of dihydropyrimidine dehydrogenase (DPD).
- •Peripheral nerve disease ≥ NCI CTC AE grade
Arms & Interventions
Experiment group
Pegylated Liposomal Doxorubicin + Oxaliplatin + Capecitabine + Tislelizumab; reapt every 21 days.
Intervention: PLD
Experiment group
Pegylated Liposomal Doxorubicin + Oxaliplatin + Capecitabine + Tislelizumab; reapt every 21 days.
Intervention: Oxaliplatin
Experiment group
Pegylated Liposomal Doxorubicin + Oxaliplatin + Capecitabine + Tislelizumab; reapt every 21 days.
Intervention: Capecitabine
Experiment group
Pegylated Liposomal Doxorubicin + Oxaliplatin + Capecitabine + Tislelizumab; reapt every 21 days.
Intervention: Tislelizumab
Outcomes
Primary Outcomes
Pathological complete remission rate
Time Frame: 4-month
Completely resected tumor specimens and all sampled regional lymph nodes were detected without residual infiltration (ie ypT0 ypN0 in AJCC staging version 8.0)
Secondary Outcomes
- Objective response rate(3-month)
- R0 resection rate(4-month)
- Progress-free survival(3-year)
- 3-year PFS rate(3-year)
- 3-year overall survival rate(3-year)