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

Yongxu Jia

Status: Not yet enrolling

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

Treatments: Other: ICIs(Immune checkpoint inhibitors)

Study type: Observational

Funder types: Other

Identifiers

NCT06814548

GC-2L-ICI-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

ICIs retreatment

Description:

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.

Treatment:

Other: ICIs(Immune checkpoint inhibitors)