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

Phase 2

Recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: tirelizumab; Drug: chemotherapy with oxaliplatin + heroda

• Registration Number: NCT05844371
• Lead Sponsor: Yixing People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-25
• Study First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-06-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	tirelizumab	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.
Control group	chemotherapy with oxaliplatin + heroda	6 cycles of oxaliplatin + heroda regimen chemotherapy.
study group	chemotherapy with oxaliplatin + heroda	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.

Primary Outcome Measures

Name	Time	Method
The 1-year DFS rate	1 year	within one year from onset

Trial Locations

Locations (1)

Yixing People's Hospital; 🇨🇳 Yixing, Jiangsu, China