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

Gastric Cancer Clinical Trial

Official title:

Clinical Efficacy and Safety of Adjuvant Immunotherapy (Tirelizumab) Plus Chemotherapy Versus Adjuvant Chemotherapy Alone in Lymph Node Positive Patients With Gastric Cancer After D2 Radical Resection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844371
• Other study ID #: YixingPH
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2023
• Source: Yixing People's Hospital
• Contact: Yan Zhou
• Phone: 13961550236
• Email: staff260[@]yxph.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• tirelizumab
Tirelizumab (200 mg, q3w) was added and maintained until one year, starting with adjuvant chemotherapy after surgery.
• chemotherapy with oxaliplatin + heroda
chemotherapy with oxaliplatin + heroda

Locations

Country	Name	City	State
China	Yixing People's Hospital	Yixing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yixing People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Lee SH, Lee HT, Lim H, Kim Y, Park UB, Heo YS. Crystal structure of PD-1 in complex with an antibody-drug tislelizumab used in tumor immune checkpoint therapy. Biochem Biophys Res Commun. 2020 Jun 18;527(1):226-231. doi: 10.1016/j.bbrc.2020.04.121. Epub 2 — View Citation

Shen L, Guo J, Zhang Q, Pan H, Yuan Y, Bai Y, Liu T, Zhou Q, Zhao J, Shu Y, Huang X, Wang S, Wang J, Zhou A, Ye D, Sun T, Gao Y, Yang S, Wang Z, Li J, Wu YL. Tislelizumab in Chinese patients with advanced solid tumors: an open-label, non-comparative, phas — View Citation

Zhang T, Song X, Xu L, Ma J, Zhang Y, Gong W, Zhang Y, Zhou X, Wang Z, Wang Y, Shi Y, Bai H, Liu N, Yang X, Cui X, Cao Y, Liu Q, Song J, Li Y, Tang Z, Guo M, Wang L, Li K. The binding of an anti-PD-1 antibody to FcgammaRIota has a profound impact on its biological functions. Cancer Immunol Immunother. 2018 Jul;67(7):1079-1090. doi: 10.1007/s00262-018-2160-x. Epub 2018 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 1-year DFS rate	within one year from onset	1 year