Predicting Gastric Cancer Response to Chemo With Multimodal AI Model

A Radio-Pathomic Multimodal Machine Learning Model for Predicting Pathological Complete Response to Neoadjuvant Chemotherapy in Advanced Gastric Cancer: A Retrospective Observational Study

This study aims to develop a multimodal model combining radiomic and pathomic features to predict pathological complete response (pCR) in advanced gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). The researchers intended to collected pre-intervention CT images and pathological slides from patients, extract radiomic and pathomic features, and build a prediction model using machine learning algorithms. The model will be validated using a separate cohort of patients. This research intend to build a radiomic-pathomic model that can outperform models based on either radiomic or pathomic features alone, aiming to improve the prediction of pCR in gastric cancer.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Chemotherapy Effect
• Intervention / Treatment: Drug: Neoadjuvant chemotherapy with radical tumor resection surgery

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Yonghe Chen, MD; Phone Number: +86 135 6038 6150; Email: chenyhe@mail2.sysu.edu.cn
• Study Contact Backup: Name: Junsheng Peng, MD; Phone Number: +86 13802963578; Email: pengjsh@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Xiangen Lu, Master; Phone Number: +86 20 3837 9764; Email: zslyllb@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received neoadjuvant chemotherapy and radical gastrectomy;

Description

Inclusion Criteria:

• patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received NAC and radical gastrectomy;
• patients who underwent abdominal multidetector computed tomography (CT) inspection, gastroscope, and tumor tissue biopsy before any intervention started;
• Lesions that are assessable according to The Response Evaluation Criteria in Solid Tumors Version 1.1

Exclusion Criteria:

• Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection;
• patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling;
• patients with insufficient data.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neoadjuvant chemotherapy with radical tumor resection surgery; (i) Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection; (ii) patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling; (iii) patients with insufficient data.	Drug: Neoadjuvant chemotherapy with radical tumor resection surgery; All patients were pathologically diagnosed as advanced gastric cancer, all receive neoadjuvant chemotherapy, after the completion of neoadjuvant chemotherapy, all patients receive radical tumor resection surgery (partial gastrectomy or total gastrectomy, as proper).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response	Pathological complete response (pCR) was defined as no viable cells remained in the primary tumor lesions and the dissected lymph nodes.	Assessed within 30 days after radical resection surgery.

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Principal Investigator: Junsheng Peng, MD, The Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): September 30, 2022
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 8, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 8, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Advanced gastric cancer; Neoadjuvant chemotherapy; Pathological complete response; Multimodal
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: E2021088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data that support the findings of this study are available from Dr. Junsheng Peng (E-mail: pengjsh@mail.sysu.edu.cn) upon reasonable request.

Drug and device information, study documents

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