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

Not yet recruiting

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

• Registration Number: NCT06814548
• Lead Sponsor: Yongxu Jia

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Study Start: 2025-02-10
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival (OS)	12 months	Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Progression-free survival (PFS)	12 months	Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first

Secondary Outcome Measures

Name	Time	Method
disease control rate (DCR)	12 months	The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects
safety	12 months	Adverse events (AEs) were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
objective response rate (ORR)	12 months	The proportion of subjects with complete response (CR) and partial response (PR) in total subjects