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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Retreatment; Gastric Cancer, Gastroesophageal Junction Cancer; Immune Checkpoint Inhibitors (ICIs); Second-line
• Intervention / Treatment: Other: ICIs(Immune checkpoint inhibitors)

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Yongxu Jia Doctor; Phone Number: 0371-66271156; Email: jiayongxu111@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: ICIs(Immune checkpoint inhibitors); N

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	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	12 months
overall survival (OS)	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	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yongxu Jia

Study record dates

Study Major Dates

• Study Start (Estimated): February 10, 2025
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Immune Checkpoint Inhibitors
• Other Study ID Numbers: GC-2L-ICI-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No