Research on Intelligent Screening and Decision-making for Neoadjuvant Therapy in Locally Advanced Gastric Cancer Based on Multi-omics Integration
Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Gastrointestinal Department of First Affiliated Hospital of Zhejiang University
RECRUITING
Hanzhou
Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
RECRUITING
Hanzhou
Gastrointestinal Department of Zhejiang Cancer Hospital
RECRUITING
Hanzhou
Shaoxing Shangyu People's Hospital
RECRUITING
Shaoxing
Contact Information
Primary
Jian Chen
zrchenjian@zju.edu.cn
+86-13957102733
Time Frame
Start Date:2024-07-01
Estimated Completion Date:2025-12-01
Participants
Target number of participants:120
Treatments
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.