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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYongxu Jia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

patients had other malignancies within the past 5 years;

lack of survival and clinical efficacy data;

combined radiotherapy regimens in the second-line treatment.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • ICIs(Immune checkpoint inhibitors)

    Other intervention

    N

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: ICIs retreatment1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months

Secondary outcomes

1

objective response rate (ORR)

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

Time frame
12 months
2

disease control rate (DCR)

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

Time frame
12 months
3

safety

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

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yongxu Jia

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Sponsor institution

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