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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer; Magnetic Resonance Imaging; Neoadjuvant Chemotherapy; Neoadjuvant Immunotherapy; Tomography, X-Ray Computed
• Intervention / Treatment: Drug: PD-1 inhibitor

Detailed Description

With the gradual development of neoadjuvant immunotherapy and/or chemotherapy in the clinic, the pCR has become more and more accessible in the AGC. Preoperative accurate prediction of pCR is of great clinical significance. The contrast-enhanced CT and 3.0T MRI were carried out in patients within 1 week prior to commencing neoadjuvant treatment, as well as 1 week within surgery after the completion of neoadjuvant treatment, respectively. Based on the information extracted from the CT/MRI, the clinical completed response (cCR) and the clinical T staging were compared with pCR, pathologic T staging. The pathologic results were considered as the golden standard. With the ROC curve analysis, the diagnosis coincidence rate, sensitivity and specificity were assessed. The AI prediction model would be constructed and trained. The depth convolution neural network based on contrast-enhanced CT and multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and histopathologic response, could further help to improve the prediction of response of gastric cancer treated with systematic therapy. The abdominal contrast-enhanced CT will focus on parameters: Local T Staging, nodal status, diameter, according to RECIST 1.1. MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will focus on parameters: DWI & ADC value (preferably on a single camera with reproducible ADC value), Local T Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: quan wang, MD; Phone Number: 15843073207; Email: wquan@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with a history of previous chemotherapy or immunotherapy.
2. The patients couldn't perform MSCT or MR scanning or artefacts affect the evaluation.
3. The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy.
4. The patients refuse to participate in the project.
5. Pregnancy, lactation or inadequate contraception
6. Pacemaker or implanted defibrillator
7. Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study.
8. Other situations considered by investigators, which not meet the inclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; SOX regimen for 3 cycles and/or PD-1 inhibitor before surgery; Other Names: Oxaliplatin; Tiggio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of CT and MRI after the neoadjuvant treatment for pathologic T staging	To evaluate the T staging of gastric cancer treated with neoadjuvant treatment through CT and MRI.	up to 2 year
Predictive value of CT and MRI after the neoadjuvant treatment for pathologic response according to the Tumor Regression Grading (TRG)	Pathological tumour regression grading (Mandard criterion): from 1 to 5 grading.	up to 2 year
Prediction model based on CT and MRI of response in AGC	To construct a model, a depth convolution neural network based on contrast-enhanced CT and multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and histopathologic response, could further help to improve the prediction of response of gastric/rectal cancer treated with systematic therapy.	up to 2 year

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Principal Investigator: quan wang, MD, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 30, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Oxaliplatin; Immune Checkpoint Inhibitors
• Other Study ID Numbers: STARS-GC03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No