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Not yet recruiting NCT06814548

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICIs(Immune checkpoint inhibitors).
Who it may be relevant to
Registry conditions: Gastric Cancer, Gastroesophageal Junction Cancer, Immune Checkpoint Inhibitors (ICIs), Second-line, Retreatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other ICIs(Immune checkpoint inhibitors)
    N

Primary outcome measures

  • Progression-free survival (PFS) [Time frame: 12 months]
  • overall survival (OS) [Time frame: 12 months]
Secondary outcome measures (3)
  • objective response rate (ORR) [Time frame: 12 months]
  • disease control rate (DCR) [Time frame: 12 months]
  • safety [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06814548 · GC-2L-ICI-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗