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

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
tirelizumab
chemotherapy with oxaliplatin + heroda
Sponsored by
Yixing People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yixing People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group

Control group

Arm 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.

6 cycles of oxaliplatin + heroda regimen chemotherapy.

Outcomes

Primary Outcome Measures

The 1-year DFS rate
within one year from onset

Secondary Outcome Measures

Full Information

First Posted
April 25, 2023
Last Updated
May 3, 2023
Sponsor
Yixing People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05844371
Brief Title
Efficacy and Safety of Tirelizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Lymph Node Positive Gastric Cancer After Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yixing People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
6 cycles of oxaliplatin + heroda regimen chemotherapy.
Intervention Type
Drug
Intervention Name(s)
tirelizumab
Intervention Description
Tirelizumab (200 mg, q3w) was added and maintained until one year, starting with adjuvant chemotherapy after surgery.
Intervention Type
Drug
Intervention Name(s)
chemotherapy with oxaliplatin + heroda
Intervention Description
chemotherapy with oxaliplatin + heroda
Primary Outcome Measure Information:
Title
The 1-year DFS rate
Description
within one year from onset
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhou
Phone
13961550236
Email
staff260@yxph.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhou
Organizational Affiliation
Yixing People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Yixing People's Hospital
City
Yixing
State/Province
Jiangsu
ZIP/Postal Code
214200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihong Cao
Phone
0510-87921000
Email
bgs@yxph.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29687231
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.
Results Reference
background
PubMed Identifier
32446372
Citation
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 2020 May 1.
Results Reference
result
PubMed Identifier
32561638
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, phase 1/2 study. J Immunother Cancer. 2020 Jun;8(1):e000437. doi: 10.1136/jitc-2019-000437. Erratum In: J Immunother Cancer. 2020 Jul;8(2):
Results Reference
result

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

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