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First-Line and Neoadjuvant Immunotherapy for Gastric Cancer | Clinical Trials | Clareo Health

RECRUITING

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

NCT06727981•Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Key Dates

Start Date

January 15, 2022

Primary Completion Date

January 15, 2027

Completion Date

January 15, 2028

Last Updated

December 11, 2024

Enrollment

500

ESTIMATED participants

Conditions

Advanced Gastric CancerLocally Advanced Gastric Carcinoma

Interventions

ICI plus Chemothearpy

DRUG

Chemotherapy

DRUG

Contacts

Lian Liu, MD

CONTACT

0531-82169851 tounao@126.com

Song Li, MD

CONTACT

0531-82169851

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

Inclusion Criteria

Exclusion Criteria

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