Clinical trial · Observational
Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma
Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma by Biopsy Specimens.
NCT06490003CI-TRIAL-00117797recruitingClinicalTrials.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)
Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| DNA Methylation | — | UNRESOLVED | — |
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluoro Uracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Chemotherapy response patients.
- description
- Responders according to the response evaluation criteria in solid tumors (RECIST). A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)
- interventionNames
- Drug: Fluoro Uracil
- label
- Chemotherapy non-response patients
- description
- Responders according to the response evaluation criteria in solid tumors (RECIST). A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)
- interventionNames
- Drug: Fluoro Uracil
Primary outcomes (1)
- measure
- Overall response rate(Chemotherapy)
- timeFrame
- 1year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who had histologically confirmed esophageal squamous cell carcinoma. 2. Patients who had undergone chemotherapy. 3. Patients receiving initial chemotherapy 4. Written informed consent following full study information is provided to the patient. Exclusion Criteria: 1. Patients for whom a preoperative biopsy sample cannot be obtained 2. Patients who cannot assess at 2 months later after chemotherapy. 3. Patients with multiple cancers.
References
Publications (11)
- BACKGROUNDBray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID 38572751
- BACKGROUNDMorgan E, Soerjomataram I, Rumgay H, Coleman HG, Thrift AP, Vignat J, Laversanne M, Ferlay J, Arnold M. The Global Landscape of Esophageal Squamous Cell Carcinoma and Esophageal Adenocarcinoma Incidence and Mortality in 2020 and Projections to 2040: New Estimates From GLOBOCAN 2020. Gastroenterology. 2022 Sep;163(3):649-658.e2. doi: 10.1053/j.gastro.2022.05.054. Epub 2022 Jun 4. PMID 35671803
- BACKGROUNDShah MA, Kennedy EB, Catenacci DV, Deighton DC, Goodman KA, Malhotra NK, Willett C, Stiles B, Sharma P, Tang L, Wijnhoven BPL, Hofstetter WL. Treatment of Locally Advanced Esophageal Carcinoma: ASCO Guideline. J Clin Oncol. 2020 Aug 10;38(23):2677-2694. doi: 10.1200/JCO.20.00866. Epub 2020 Jun 22. PMID 32568633
- BACKGROUNDMacedo-Silva C, Constancio V, Miranda-Goncalves V, Leite-Silva P, Salta S, Lobo J, Guimaraes R, Carvalho-Maia C, Gigliano D, Farinha M, Sousa O, Henrique R, Jeronimo C. DNA methylation biomarkers accurately detect esophageal cancer prior and post neoadjuvant chemoradiation. Cancer Med. 2023 Apr;12(7):8777-8788. doi: 10.1002/cam4.5623. Epub 2023 Jan 20. PMID 36670548
- BACKGROUNDZhang Y, Cao Y, Zhang J, Huang M, Roy P, Huang B, Yang H, Rong Y, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Lin J, Zhang J, Fu J, He J, Li H. Lymph Node Ratio Improves Prediction of Overall Survival in Esophageal Cancer Patients Receiving Neoadjuvant Chemoradiotherapy: A National Cancer Database Analysis. Ann Surg. 2023 Jun 1;277(6):e1239-e1246. doi: 10.1097/SLA.0000000000005450. Epub 2022 Jul 6. PMID 35797545
- BACKGROUNDZhang XY, Yan WP, Sun Y, Li XT, Chen Y, Fan MY, Wu Y, Liang Z, Xiong HC, Wang ZL, Sun YS, Chen KN. CT Signs Can Predict Treatment Response and Long-Term Survival: A Study in Locally Advanced Esophageal Cancer with Preoperative Chemotherapy. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S1380-7. doi: 10.1245/s10434-015-4531-2. Epub 2015 May 5.