Immune Checkpoint Inhibitors (ICIs) Retreatment in Second-line Treatment of Advanced Gastric Cancer: a Retrospective, Real-world Study

NCT ID: NCT06814548

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2025-05-31

Brief Summary

This is a single-center, retrospective, observational, real-world study. We collected general and clinical data of patients with advanced gastric cancer who were admitted to the First Affiliated Hospital of Zhengzhou University from January 2018 to July 2024.

Detailed Description

All patients received combination therapy with ICIs inhibitors for at least 2 cycles in the first-line and at least 2 cycles of ICI inhibitor-based therapy in the second-line after first-line progression. The efficacy and safety of treatment were evaluated, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), Pattern of immune progression after cross-line therapy, grade 3-5 treatment-related adverse events (TRAEs), and immune-related adverse events (irAEs). Cox regression model was used to investigate the influence of multiple factors on survival.

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer; Immune Checkpoint Inhibitors (ICIs); Second-line; Retreatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ICIs retreatment

Histologically confirmed metastatic or advanced GC/GEJC; Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting; Receiving at least 2 cycles of ICI-based second-line therapy; ECOG PS 0 or 1; Radiographic response was also assessed during treatment and survival.

ICIs(Immune checkpoint inhibitors)

Intervention Type: OTHER

N

Interventions

ICIs(Immune checkpoint inhibitors)

N

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed metastatic or advanced GC/GEJC;
• Received at least 2 cycles of anti-PD-1 or PD-L1 based therapy in the first-line setting;
• Receiving at least 2 cycles of ICI-based second-line therapy;
• ECOG PS 0 or 1;
• Radiographic response was also assessed during treatment and survival.

Exclusion Criteria

• patients had other malignancies within the past 5 years;
• lack of survival and clinical efficacy data;
• combined radiotherapy regimens in the second-line treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yongxu Jia

OTHER

Sponsor Role: lead

Responsible Party

Yongxu Jia

Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Yongxu Jia Doctor

Role: CONTACT

jiayongxu111@126.com

0371-66271156

Other Identifiers

GC-2L-ICI-2024

Identifier Type: -

Identifier Source: org_study_id