First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

NCT06727981 | Recruiting

• 1 other identifier: EABI-GC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Gastric Cancer; Locally Advanced Gastric Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The time from the starting date of study drug to death

  12 months after the last subject participating in

Secondary Outcomes (7)

• 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

Study Arms (2)

ICI plus chemotherapy

Drug: ICI plus Chemothearpy

Chemotherapy

Drug: Chemotherapy

Interventions

ICI plus Chemothearpy DRUG

This intervention involves the administration of immune checkpoint inhibitors (ICIs) in combination with standard chemotherapy.

ICI plus chemotherapy

Chemotherapy DRUG

This intervention involves the administration of standard chemotherapy alone.

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collect the peripheral blood and feces of patients before and after treatment, and obtain pathological sections if possible.

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Lian Liu, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lian Liu, MD

CONTACT

0531-82169851; tounao@126.com

Song Li, MD

CONTACT

0531-82169851

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: December 11, 2024
• Study Start: January 15, 2022
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)