Research on Intelligent Screening and Decision-making for Neoadjuvant Therapy in Locally Advanced Gastric Cancer Based on Multi-omics Integration

NCT06396143 | Recruiting

• 1 other identifier: WKJ-ZJ-2310
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

In this study, investigators utilize a radiopathomics integrated Artificial Intelligence (AI) supportive system to predict tumor response to neoadjuvant chemoradiotherapy (nCRT) before its administration for patients with locally advanced gastric cancer (LAGC). By the system, the postoperative tumor regression grade (TRG) of the participants will be identified based on the radiopathomics features extracted from the pre-nCRT Enhanced CT and biopsy images. The ability to predict TRG will be validated in this multicenter, prospective clinical study.

Conditions

Locally Advanced Gastric Carcinoma

Keywords

Gastric cancer; Neoadjuvant chemotherapy; Immunotherapy; Targeted therapy

Outcome Measures

Primary Outcomes (1)

• The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of the radiopathomics artificial intelligence model

  Calculate the area under the receiver operating characteristic (ROC) curve (AUC) of the artificial intelligence model for radiomics to predict the postoperative pathological TRG grading index in LAGC patients treated with nCRT.

  baseline

Secondary Outcomes (2)

• The specificity of the radiopathomics artificial intelligence model

  baseline

• The sensitivity of the radiopathomics artificial intelligence model

  baseline

Study Arms (3)

Neoadjuvant chemotherapy group

a. Pathological diagnosis of gastric adenocarcinoma; b. The CT evaluation of gastric cancer is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis; c. Acceptance criteria for 2-4 courses of 5-FU+platinum based neoadjuvant chemotherapy regimen. D2 gastric cancer radical surgery will be performed after the neoadjuvant treatment regimen； e. Enhanced CT images and digital images of HE stained gastroscopy biopsy sections before neoadjuvant therapy are available; f. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers.

Neoadjuvant chemotherapy combined with PD1 or PDL1 group

a. Pathological diagnosis of gastric adenocarcinoma; b. The CT evaluation of gastric cancer is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis; c. Acceptance criteria for a 2-4 course treatment regimen based on 5-FU+platinum neoadjuvant chemotherapy combined with anti PD-L1 therapy; d. D2 gastric cancer radical surgery was performed after the new adjuvant treatment regimen; e. Enhanced CT images and digital images of HE stained gastroscopy biopsy sections before neoadjuvant therapy are available; f. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers.

Neoadjuvant chemotherapy combined with trastuzumab group

a. Pathological diagnosis of gastric adenocarcinoma; b. The CT evaluation of gastric cancer is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis; c. Acceptance criteria for 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy combined with trastuzumab regimen; d. D2 gastric cancer radical surgery was performed after the new adjuvant treatment regimen; e. Enhanced CT images and digital images of HE stained gastroscopy biopsy sections before neoadjuvant therapy are available; f. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population in the study is LAGC patients who plan to receive standard neoadjuvant concurrent chemotherapy or combination immunotherapy and targeted therapy, but the tumor pathological response is unknown.

You may qualify if:

• Pathological diagnosis of gastric adenocarcinoma
• Gastric cancer CT evaluation is clinical stage II-IVa (≥ T3, and/or lymph node positive), with or without local tissue or organ invasion, and no distant metastasis.
• Acceptance criteria for 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy regimen, or 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy combined with trastuzumab regimen, or 2-4 courses of 5-FU+platinum neoadjuvant chemotherapy combined with anti-PD-L1 treatment regimen.
• D2 gastric cancer radical surgery after neoadjuvant therapy
• Digital images of enhanced CT images and HE stained gastroscopy biopsy sections before neoadjuvant therapy are available.
• Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers.

You may not qualify if:

• Has a history of other tumors.
• Insufficient imaging quality of CT or biopsy slides, unable to obtain features.
• Unable to extract molecular information related to research from organizational samples.
• Interruption of neoadjuvant therapy course for any reason.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (4)

Gastrointestinal Department of First Affiliated Hospital of Zhejiang University

Hanzhou, Zhejiang, 310000, China

RECRUITING

Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Hanzhou, Zhejiang, 310000, China

RECRUITING

Gastrointestinal Department of Zhejiang Cancer Hospital

Hanzhou, Zhejiang, 310000, China

RECRUITING

Shaoxing Shangyu People's Hospital

Shaoxing, Zhejiang, 312000, China

RECRUITING

Related Publications (1)

• Feng L, Liu Z, Li C, Li Z, Lou X, Shao L, Wang Y, Huang Y, Chen H, Pang X, Liu S, He F, Zheng J, Meng X, Xie P, Yang G, Ding Y, Wei M, Yun J, Hung MC, Zhou W, Wahl DR, Lan P, Tian J, Wan X. Development and validation of a radiopathomics model to predict pathological complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer: a multicentre observational study. Lancet Digit Health. 2022 Jan;4(1):e8-e17. doi: 10.1016/S2589-7500(21)00215-6.

  PMID: 34952679 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jian Chen

CONTACT

+86-13957102733; zrchenjian@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastrointestinal Surgery, Second affiliated hospital of Zhejiang university School of Medicine

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)