Tumor Microenvironment in Gastric Cancer Patients Treated With Combined Immunotherapy and Chemotherapy

NCT ID: NCT06202781

Last Updated: 2024-01-12

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

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-07-31

Brief Summary

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The goal of this study is to analyze the tumor microenvironment (TME) in gastric cancer patients treated with combined immunotherapy and chemotherapy. The main questions it aims to answer are:

* Provide profiles of TME between pre-treatment and post-treatment to gain insights into the mechanisms of immunotherapy combined with chemotherapy in advanced gastric cancer
* Investigate the crucial factors affecting treatment efficacy by comparing gastric cancer patients with varying treatment responses

Detailed Description

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Conditions

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Gastric Cancer Tumor Microenvironment Immunotherapy Chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Pre-treatment

Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy

SOX plus PD-1 inhibitor

Intervention Type DRUG

S-1, Oxaliplatin and nivolumab/sintilimab

Gastroscopic biopsy

Intervention Type PROCEDURE

Gastroscopy and biopsy

Post-treatment

Advanced gastric cancer patients who have received 2 to 8 cycles of combined immunotherapy and chemotherapy

SOX plus PD-1 inhibitor

Intervention Type DRUG

S-1, Oxaliplatin and nivolumab/sintilimab

Gastroscopic biopsy

Intervention Type PROCEDURE

Gastroscopy and biopsy

Response

Advanced gastric cancer patients who have achieved complete response (CR) or partial response (PR) after receiving combined immunotherapy and chemotherapy

SOX plus PD-1 inhibitor

Intervention Type DRUG

S-1, Oxaliplatin and nivolumab/sintilimab

Gastroscopic biopsy

Intervention Type PROCEDURE

Gastroscopy and biopsy

Non-response

Advanced gastric cancer patients who have achieved stable disease (SD) or progressive disease (PD) after receiving combined immunotherapy and chemotherapy

SOX plus PD-1 inhibitor

Intervention Type DRUG

S-1, Oxaliplatin and nivolumab/sintilimab

Gastroscopic biopsy

Intervention Type PROCEDURE

Gastroscopy and biopsy

Interventions

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SOX plus PD-1 inhibitor

S-1, Oxaliplatin and nivolumab/sintilimab

Intervention Type DRUG

Gastroscopic biopsy

Gastroscopy and biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Non-bedridden, aged 18 to 70 years old;
* Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
* Histologically confirmed gastric adenocarcinoma with evaluable lesions based on RECIST 1.1;
* Advanced gastric cancer;
* Ready for receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab

Exclusion Criteria

* History of other malignant diseases in the last 5 years;
* Prior chemotherapy, radiotherapy or immunotherapy;
* Not receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xinxin Wang

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinxin Wang, MD

Role: CONTACT

0086-10-938328

Facility Contacts

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Xinxin Wang, Dr.

Role: primary

0086-10-938328

Other Identifiers

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scgc1

Identifier Type: -

Identifier Source: org_study_id

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