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First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

NCT ID: NCT06727981

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-15

Study Completion Date

2028-01-15

Brief Summary

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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

Detailed Description

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Conditions

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Advanced Gastric Cancer Locally Advanced Gastric Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICI plus chemotherapy

ICI plus Chemothearpy

Intervention Type DRUG

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

Chemotherapy

Chemotherapy

Intervention Type DRUG

This intervention involves the administration of standard chemotherapy alone.

Interventions

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ICI plus Chemothearpy

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

Intervention Type DRUG

Chemotherapy

This intervention involves the administration of standard chemotherapy alone.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Lian Liu, MD, PHD

Professor, Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lian Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lian Liu, MD

Role: CONTACT

Phone: 0531-82169851

Email: [email protected]

Song Li, MD

Role: CONTACT

Phone: 0531-82169851

Facility Contacts

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Lian Liu, MD

Role: primary

Song Li, MD

Role: backup

Other Identifiers

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EABI-GC

Identifier Type: -

Identifier Source: org_study_id