Clinical trial · Observational
Research on Intelligent Screening and Decision-making for Neoadjuvant Therapy in Locally Advanced Gastric Cancer Based on Multi-omics Integration
NCT06396143CI-TRIAL-00076661unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Gastric Carcinoma | Gastric Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Neoadjuvant chemotherapy group
- description
- 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.
- label
- Neoadjuvant chemotherapy combined with PD1 or PDL1 group
- description
- 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.
- label
- Neoadjuvant chemotherapy combined with trastuzumab group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathological diagnosis of gastric adenocarcinoma 2. 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. 3. 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. 4. D2 gastric cancer radical surgery after neoadjuvant therapy 5. Digital images of enhanced CT images and HE stained gastroscopy biopsy sections before neoadjuvant therapy are available. 6. Complete clinical diagnosis and treatment information, as well as expression information of targeted and immunotherapy related molecular markers. Exclusion Criteria: 1. Has a history of other tumors. 2. Insufficient imaging quality of CT or biopsy slides, unable to obtain features. 3. Unable to extract molecular information related to research from organizational samples. 4. Interruption of neoadjuvant therapy course for any reason.
References
Publications (1)
- BACKGROUNDFeng 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