First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

Qilu Hospital of Shandong University500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Advanced Gastric Cancer Locally Advanced Gastric Carcinoma

Interventions

ICI plus ChemothearpyDRUG

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

ChemotherapyDRUG

This intervention involves the administration of standard chemotherapy alone.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

RECRUITING

Outcomes

Primary Outcomes

Overall survival (OS)

The time from the starting date of study drug to death

Time frame: 12 months after the last subject participating in

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 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

Time frame: 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

Time frame: 3 months after the last subject participating in

Central Contacts

Lian Liu, MD

CONTACT

0531-82169851 tounao@126.com

Song Li, MD

CONTACT

0531-82169851

Data from ClinicalTrials.gov

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