Prospective Cohort Study on the Efficacy, Adverse Effects, and Biomarkers of First-Line/Neoadjuvant Therapy With Immune Checkpoint Inhibitors Combined With Chemotherapy in Advanced Gastric Cancer

Qilu Hospital of Shandong University1 site in 1 country500 target enrollmentJanuary 15, 2022

ConditionsAdvanced Gastric Cancer Locally Advanced Gastric Carcinoma

InterventionsChemotherapy ICI plus Chemothearpy

DrugsICI plus Chemothearpy Chemotherapy

Overview

Phase: Not Applicable
Intervention: Chemotherapy
Conditions: Advanced Gastric Cancer
Sponsor: Qilu Hospital of Shandong University
Enrollment: 500
Locations: 1
Primary Endpoint: Overall survival (OS)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This prospective observational study aims to evaluate the efficacy and safety of immune checkpoint inhibitors as first-line and neoadjuvant therapy for advanced gastric cancer, while also investigating relevant biomarkers to better understand their role in immunotherapy outcomes

Registry

clinicaltrials.gov

Start Date

January 15, 2022

End Date

January 15, 2028

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Qilu Hospital of Shandong University

Responsible Party

Principal Investigator

Lian Liu, MD, PHD

Professor, Chief Physician

Qilu Hospital of Shandong University

Eligibility Criteria

Inclusion Criteria

•Age 18 years old or above
•Patients with advanced gastric cancer or locally advanced gastric cancer
•Have not received any previous anti-tumor therapy
•Patients expected to receive immunotherapy for first-line or neoadjuvant therapy
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
•Adequate organ function

Exclusion Criteria

•Patients with contraindications to immunotherapy
•Have received anti-tumor treatments such as immunotherapy and chemotherapy
•Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases
•Severe chronic or active infection requires systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection. Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment
•History of allogeneic stem cell transplantation or organ transplantation

Arms & Interventions

Chemotherapy

Intervention: Chemotherapy

ICI plus chemotherapy

Intervention: ICI plus Chemothearpy

Outcomes

Primary Outcomes

Overall survival (OS)

Time Frame: 12 months after the last subject participating in

The time from the starting date of study drug to death

Secondary Outcomes

Disease Control Rate (DCR) as assessed by RECIST1.1(6 months after the last subject participating in)
Duration of response (DOR) as assessed by RECIST1.1(12 months after the last subject participating in)
Number of participants with treatment-related adverse events as assessed by CTCAE5.0(12 months after the last subject participating in)
Progression-free survival (PFS) as assessed by RECIST1.1(12 months after the last subject participating in)
Objective remission rate (ORR) as assessed by RECIST1.1(3 months after the last subject participating in)
Disease-free survival (DFS) as assessed by RECIST1.1(36 months after the last subject participating in)
Major pathological response (MPR)(3 months after the last subject participating in)