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Trial Title:
Efficacy and Safety of Tirelizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Lymph Node Positive Gastric Cancer After Surgery
NCT ID:
NCT05844371
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
tirelizumab
Description:
Tirelizumab (200 mg, q3w) was added and maintained until one year, starting with adjuvant
chemotherapy after surgery.
Arm group label:
study group
Intervention type:
Drug
Intervention name:
chemotherapy with oxaliplatin + heroda
Description:
chemotherapy with oxaliplatin + heroda
Arm group label:
Control group
Arm group label:
study group
Summary:
Lymph node positive patients after D2 radical surgery for gastric cancer, who started to
be treated at Yixing people's Hospital in April 2021, were selected and enrolled into the
study group according to the patients' wishes: immune (tirelizumab) combined with
chemotherapy (XELOX regimen) or control group: chemotherapy alone (XELOX regimen). Each
enrolled patient signed an informed consent form approved by the ethics committee,
signed, and dated. Efficacy and adverse effects were assessed in both groups.
Criteria for eligibility:
Criteria:
Inclusion criteria：(1) With a good bone marrow reserve, e. g. : leukocytes ≥ 4 × 109 / L,
neutrophils ≥ 1.5 × 109 / L, platelets ≥ 100 × 109 / L and hemoglobin ≥ 90 g / L.(2)
Cardiopulmonary function was unremarkable.(3) There were no abnormalities in liver and
kidney function. For example: creatinine ≤ 1.5 × ULN or a calculated serum creatinine
clearance ≥ 50 ml / min (calculated according to the Cockcroft Gault formula), albumin ≥
30 g / L, and total bilirubin ≤ 1.5 × ULN, alanineaminotransferase (ALT) / aspartate
aminotransferase (AST) ≤ 2 × ULN.(4) International normalized ratio / activated partial
thromboplastin time ≤ 1.5 × ULN.(5) Age older than 18 years, karonfsky performance status
(KPS) score ≥ 80, and premedication patients' bone marrow status, liver and kidney
function, and cardiopulmonary function had little impact on prognosis.
Exclusion criteria: Had a previous history of immunodeficiency, or had other acquired,
congenital immunodeficiency diseases, or a history of organ transplantation; Preexisting
thyroid dysfunction and, with medical therapy, thyroid function still cannot be
maintained within the normal range; Women who were pregnant or lactating; Those with a
history of substance abuse who are unable to abstain or who have a mental disorder.
Gender:
All
Minimum age:
30 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yixing People's Hospital
Address:
City:
Yixing
Zip:
214200
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhihong Cao
Phone:
0510-87921000
Email:
bgs@yxph.com
Start date:
April 1, 2021
Completion date:
April 1, 2024
Lead sponsor:
Agency:
Yixing People's Hospital
Agency class:
Other
Source:
Yixing People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05844371
