First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

Recruiting

• Conditions: Advanced Gastric Cancer; Locally Advanced Gastric Carcinoma
• Interventions: Drug: ICI plus Chemothearpy; Drug: Chemotherapy

• Registration Number: NCT06727981
• Lead Sponsor: Qilu Hospital of Shandong University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-01-15
• Study First Submitted: 2024-09-27
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-10
• Last Update Submitted: 2024-12-10
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2027-01-15
• Study Completion: 2028-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICI plus chemotherapy	ICI plus Chemothearpy	-
Chemotherapy	Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	12 months after the last subject participating in	The time from the starting date of study drug to death

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR) as assessed by RECIST1.1	6 months after the last subject participating in	The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects.
Duration of response (DOR) as assessed by RECIST1.1	12 months after the last subject participating in	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.
Number of participants with treatment-related adverse events as assessed by CTCAE5.0	12 months after the last subject participating in	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).
Progression-free survival (PFS) as assessed by RECIST1.1	12 months after the last subject participating in	The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first
Objective remission rate (ORR) as assessed by RECIST1.1	3 months after the last subject participating in	The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Disease-free survival (DFS) as assessed by RECIST1.1	36 months after the last subject participating in	The period from treatment until the occurrence of disease recurrence, progression, or death.
Major pathological response (MPR)	3 months after the last subject participating in	he percentage of residual viable tumor cells in the resected specimen that is ≤10% after neoadjuvant therapy.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China