Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06814548

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICIs(Immune checkpoint inhibitors)

Other

N

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 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

  2. overall survival (OS)

    Time frame: 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 outcomes

  1. objective response rate (ORR)

    Time frame: 12 months

    The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

  2. disease control rate (DCR)

    Time frame: 12 months

    The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects

  3. safety

    Time frame: 12 months

    Adverse events (AEs) were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongxu Jia Doctor

CONTACT

[email protected]

0371-66271156

Sponsors and collaborators

Lead sponsor

Yongxu Jia

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.