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

NCT06814548 | Not Yet Recruiting

• 1 other identifier: GC-2L-ICI-2024
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• objective response rate (ORR)

  12 months

• disease control rate (DCR)

  12 months

• safety

  12 months

Study Arms (1)

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)

Interventions

ICIs(Immune checkpoint inhibitors) OTHER

N

ICIs retreatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yongxu Jia: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Immunohistochemical detection

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Yongxu Jia Doctor

CONTACT

0371-66271156; jiayongxu111@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: February 10, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share