NCT06202781

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 1, 2024

Last Update Submit

January 10, 2024

Conditions

Gastric CancerTumor MicroenvironmentImmunotherapyChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Single-cell profiling

    Single-cell transcriptome and immune repertoire sequencing

    6 months

Study Arms (4)

Pre-treatment

Advanced gastric cancer patients prior to receiving combined immunotherapy and chemotherapy

Drug: SOX plus PD-1 inhibitorProcedure: Gastroscopic biopsy

Post-treatment

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

Drug: SOX plus PD-1 inhibitorProcedure: Gastroscopic biopsy

Response

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

Drug: SOX plus PD-1 inhibitorProcedure: Gastroscopic biopsy

Non-response

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

Drug: SOX plus PD-1 inhibitorProcedure: Gastroscopic biopsy

Interventions

SOX plus PD-1 inhibitorDRUG

S-1, Oxaliplatin and nivolumab/sintilimab

Non-responsePost-treatmentPre-treatmentResponse
Gastroscopic biopsyPROCEDURE

Gastroscopy and biopsy

Non-responsePost-treatmentPre-treatmentResponse

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced gastric cancer patients receiving S-1 plus oxaliplatin chemotherapy and either nivolumab or sintilimab

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic Uses

Central Study Contacts

Xinxin Wang, MD

CONTACT

0086-10-938328wangxx301@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 1, 2024

First Posted

January 12, 2024

Study Start

July 1, 2022

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

CN(1)