First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

Shandong University

Status: Enrolling

Conditions: Locally Advanced Gastric Carcinoma; Advanced Gastric Cancer

Treatments: Drug: Chemotherapy; Drug: ICI plus Chemothearpy

Study type: Observational

Funder types: Other

Identifiers

NCT06727981

EABI-GC

Details and patient eligibility

About

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

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

500 participants in 2 patient groups

ICI plus chemotherapy

Treatment:

Drug: ICI plus Chemothearpy

Chemotherapy

Treatment:

Drug: Chemotherapy