First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Gastric Cancer; Locally Advanced Gastric Carcinoma
• Intervention / Treatment: Drug: ICI plus Chemothearpy; Drug: Chemotherapy

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Lian Liu, MD; Phone Number: 0531-82169851; Email: tounao@126.com
• Study Contact Backup: Name: Song Li, MD; Phone Number: 0531-82169851

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Lian Liu, MD; Phone Number: 0531-82169851; Email: tounao@126.com
      • Contact: Song Li, MD; Phone Number: 0531-82169851

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with pathologically defined, locally inoperable or advanced gastric cancer who have not received any previous anti-tumor therapy and are expected to receive immunotherapy.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with contraindications to immunotherapy
2. Have received anti-tumor treatments such as immunotherapy and chemotherapy
3. 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
4. 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
5. History of allogeneic stem cell transplantation or organ transplantation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chemotherapy	Drug: Chemotherapy; This intervention involves the administration of standard chemotherapy alone.
ICI plus chemotherapy	Drug: ICI plus Chemothearpy; This intervention involves the administration of immune checkpoint inhibitors (ICIs) in combination with standard chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	The time from the starting date of study drug to death	12 months after the last subject participating in

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate (DCR) as assessed by RECIST1.1	The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects.	6 months after the last subject participating in
Duration of response (DOR) as assessed by RECIST1.1	The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.	12 months after the last subject participating in
Number of participants with treatment-related adverse events as assessed by CTCAE5.0	Incidence and severity of adverse effects associated with the treatments, categorized by type and grade according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0).	12 months after the last subject participating in
Progression-free survival (PFS) as assessed by RECIST1.1	The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first	12 months after the last subject participating in
Objective remission rate (ORR) as assessed by RECIST1.1	The proportion of subjects with complete response (CR) and partial response (PR) in total subjects	3 months after the last subject participating in
Disease-free survival (DFS) as assessed by RECIST1.1	The period from treatment until the occurrence of disease recurrence, progression, or death.	36 months after the last subject participating in
Major pathological response (MPR)	he percentage of residual viable tumor cells in the resected specimen that is ≤10% after neoadjuvant therapy.	3 months after the last subject participating in

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Lian Liu, MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2028

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: EABI-GC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No