Efficacy and Safety of Tirelizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Lymph Node Positive Gastric Cancer After Surgery
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yan Zhou
- Phone Number: 13961550236
- Email: staff260@yxph.com
Study Locations
-
-
Jiangsu
-
Yixing, Jiangsu, China, 214200
- Recruiting
- Yixing People'S Hospital
-
Contact:
- Zhihong Cao
- Phone Number: 0510-87921000
- Email: bgs@yxph.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
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.
|
Tirelizumab (200 mg, q3w) was added and maintained until one year, starting with adjuvant chemotherapy after surgery.
chemotherapy with oxaliplatin + heroda
|
|
Active Comparator: Control group
6 cycles of oxaliplatin + heroda regimen chemotherapy.
|
chemotherapy with oxaliplatin + heroda
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The 1-year DFS rate
Time Frame: 1 year
|
within one year from onset
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yan Zhou, Yixing People'S Hospital
Publications and helpful links
General Publications
- 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):
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YixingPH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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