The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)

Official title

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

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.

Interventions

• Drug PLD
  20mg/m2, day 1, q3w
• Drug Oxaliplatin
  130 mg/m2, day 1, q3w
• Drug Capecitabine
  1000 mg/m2, days 1-14, q3w
• Drug Tislelizumab
  200 mg, day 1, q3w

Primary outcome measures

• Pathological complete remission rate [Time frame: 4-month]

Secondary outcome measures (5)

• Objective response rate [Time frame: 3-month]
• R0 resection rate [Time frame: 4-month]
• 3-year overall survival rate [Time frame: 3-year]
• Progress-free survival [Time frame: 3-year]
• 3-year PFS rate [Time frame: 3-year]

Eligibility criteria

Inclusion criteria

• Age: 18\~75 years old.
• Karnofsky Performance Status Score ≥70.
• 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;
• No serious concomitant diseases that make the survival time < 5 years.
• Agree and be able to comply with the protocol during the study period.
• Provide written informed consent before entering the study.

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 2. However, the patients only with deep tendon reflex (DTR) disappears do not need to be excluded.
• Organ transplantation requires immunosuppressive therapy.
• Severe uncontrolled repeated infections, or other serious uncontrolled concomitant diseases.
• Moderate or severe renal damage \[creatinine clearance ≤50ml/min (calculated according to Cockroft and Gault equation), or serum creatinine> ULN\].
• Acute or chronic active hepatitis B, hepatitis C infection, hepatitis B virus (HBV) DNA>2000IU/ml or 10\^4 copies/ml, hepatitis C virus (HCV) RNA>10\^3 copies/ml, hepatitis B surface antigen (HbsAg) is positive at the same time as anti-HCV antibody.
• Allergic to any research drug ingredients.
• Participating in other trials within 4 weeks before enrollment.
• Not suitable to participate in this trial for any reason judged by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai General Hospital — Shanghai

Identifiers

NCT: NCT05536102 · CSPC-DMS-GC-04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗