NCT05844371

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

2.2 years

First QC Date

April 25, 2023

Last Update Submit

May 3, 2023

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • The 1-year DFS rate

    within one year from onset

    1 year

Study Arms (2)

study group

EXPERIMENTAL

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.

Drug: tirelizumabDrug: chemotherapy with oxaliplatin + heroda

Control group

ACTIVE COMPARATOR

6 cycles of oxaliplatin + heroda regimen chemotherapy.

Drug: chemotherapy with oxaliplatin + heroda

Interventions

tirelizumabDRUG

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

study group
chemotherapy with oxaliplatin + herodaDRUG

chemotherapy with oxaliplatin + heroda

Control groupstudy group

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yixing People's Hospital

Yixing, Jiangsu, 214200, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 29687231BACKGROUND

  • 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.

    PMID: 32446372RESULT

  • 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.

    PMID: 32561638RESULT

  • 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.

    PMID: 37975371DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug TherapyOxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCoordination ComplexesOrganic Chemicals

Study Officials

  • Yan Zhou

    Yixing People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Yan Zhou

CONTACT

13961550236staff260@yxph.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

April 1, 2021

Primary Completion

June 1, 2023

Study Completion

April 1, 2024

Last Updated

May 6, 2023

Record last verified: 2023-04

Locations

CN(1)