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

NCT ID: NCT05844371

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-04-01

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

tirelizumab

Intervention Type: DRUG

Tirelizumab (200 mg, q3w) was added and maintained until one year, starting with adjuvant chemotherapy after surgery.

chemotherapy with oxaliplatin + heroda

Intervention Type: DRUG

chemotherapy with oxaliplatin + heroda

Control group

6 cycles of oxaliplatin + heroda regimen chemotherapy.

Group Type: ACTIVE_COMPARATOR

chemotherapy with oxaliplatin + heroda

Intervention Type: DRUG

chemotherapy with oxaliplatin + heroda

Interventions

tirelizumab

Tirelizumab (200 mg, q3w) was added and maintained until one year, starting with adjuvant chemotherapy after surgery.

Intervention Type: DRUG

chemotherapy with oxaliplatin + heroda

chemotherapy with oxaliplatin + heroda

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yixing People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhou Yan

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Zhou

Role: STUDY_DIRECTOR

Yixing People's Hospital

Locations

Yixing People's Hospital

Yixing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Zhou

Role: CONTACT

staff260@yxph.com

13961550236

Facility Contacts

Zhihong Cao

Role: primary

bgs@yxph.com

0510-87921000

References

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.

Reference Type: BACKGROUND

PMID: 29687231 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32446372 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32561638 (View on PubMed)

Shi JW, Zhou Y, Wu S. Clinical efficacy and safety of adjuvant immunotherapy (Tislelizumab) plus chemotherapy vs. adjuvant chemotherapy alone in lymph node-positive patients with gastric cancer after D2 radical resection: a prospective, 2-arm, phase II study. Eur Rev Med Pharmacol Sci. 2023 Nov;27(21):10472-10480. doi: 10.26355/eurrev_202311_34324.

Reference Type: DERIVED

PMID: 37975371 (View on PubMed)

Other Identifiers

YixingPH

Identifier Type: -

Identifier Source: org_study_id