Efficacy and Safety of Tirelizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Lymph Node Positive Gastric Cancer After Surgery

Yixing People's Hospital

Status and phase: Enrolling; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: tirelizumab; Drug: chemotherapy with oxaliplatin + heroda

Study type: Interventional

Funder types: Other

Identifiers

NCT05844371

YixingPH

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

study group

Experimental group

Description:

chemotherapy with oxaliplatin + heroda regimen (oxaliplatin 130mg / m2 D1, heroda tablets 1000mg / m2 bid d1-14, 21d repeated), during which tirelizumab (200mg, q3w) was used. After 6 cycles of chemotherapy, monotherapy with tirelizumab (200 mg, q3w) was maintained until 1 year.

Treatment:

Drug: chemotherapy with oxaliplatin + heroda

Drug: tirelizumab

Control group

Active Comparator group

Description:

6 cycles of oxaliplatin + heroda regimen chemotherapy.

Treatment:

Drug: chemotherapy with oxaliplatin + heroda