CT and MRI in Prediction of Response in Patients With Gastric Cancer Following Neoadjuvant Chemotherapy and/or Immunotherapy

NCT04913896 | Unknown

• 1 other identifier: STARS-GC03
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective and observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with advanced gastric cancer (AGC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) and CT data. This study will help the surgeons to better formulate treatment regimens for gastric cancer in the clinical practice.

Conditions

Gastric Cancer; Magnetic Resonance Imaging; Tomography, X-Ray Computed; Neoadjuvant Immunotherapy; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Predictive value of CT and MRI after the neoadjuvant treatment for developing a pCR at surgery

  Predictive value of CT and MRI after the neoadjuvant treatment for developing a pathologic complete response at surgery (Grade 0 - no viable cancer cells seen in the resection specimen).

  up to 2 year

Secondary Outcomes (3)

• Predictive value of CT and MRI after the neoadjuvant treatment for pathologic T staging

  up to 2 year

• Predictive value of CT and MRI after the neoadjuvant treatment for pathologic response according to the Tumor Regression Grading (TRG)

  up to 2 year

• Prediction model based on CT and MRI of response in AGC

  up to 2 year

Study Arms (1)

Single Group Assignment

Patients with AGC who underwent neoadjuvant immunotherapy and/or chemotherapy would recieve MRI and CT examination before and after 3 cycles treatment.

Drug: PD-1 inhibitor

Interventions

PD-1 inhibitor DRUG

SOX regimen for 3 cycles and/or PD-1 inhibitor before surgery

Also known as: Oxaliplatin, Tiggio

Single Group Assignment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with endoscopically biopsy-proven gastric cancer will receive preoperative neoadjuvant immunotherapy and/or chemotherapy.

You may qualify if:

• Age 18 Years to 80 Years
• Consecutive patients with preoperative pathologically confirmed AGC by endoscopy and preoperative imaging data (CT/MRI) were included.
• Clinical staging Ⅱ-Ⅲ according to the UICC/AJCC 8th guideline for gastric cancer without distant metastasis.
• Suitable for pre-operative chemotherapy, immunotherapy and surgical resection
• No contraindications for CT/MRI examination.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• The patients participate in this study with informed consent.

You may not qualify if:

• Patients with a history of previous chemotherapy or immunotherapy.
• The patients couldn't perform MSCT or MR scanning or artefacts affect the evaluation.
• The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy.
• The patients refuse to participate in the project.
• Pregnancy, lactation or inadequate contraception
• Pacemaker or implanted defibrillator
• Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgically removed tumor tissue

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Immune Checkpoint Inhibitors; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Coordination Complexes; Organic Chemicals

Study Officials

• quan wang, MD

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

quan wang, MD

CONTACT

15843073207; wquan@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 4, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: June 1, 2023
• Last Updated: June 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share