Clinical trial · Observational
Biomarkers and Functional Imaging in Predicting Response of Esophageal Cancer
Combination of Molecular Biomarkers and Functional Imaging in Predicting Pathologic Response and Clinical Outcomes in Squamous Esophageal Cancer Patients Who Undergo Trimodality Therapy
NCT03029793CI-TRIAL-00025589unknownClinicalTrials.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)
The purpose of this study is to determine whether combination of molecular and biomarkers with functional imaging can predict pathologic response and clinical outcomes in squamous esophageal cancer patients who undergo trimodality therapy which includes neoadjuvant chemoradiotherapy and surgery
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarkers Testing | Other | — | UNRESOLVED |
| Functional Imaging analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biomarkers and Imaging analysis
- description
- This study will prospectively collect the tissue and blood samples of locally advanced esophageal cancer patients, perform CRT resistance biomarkers testing and functional imaging analysis including SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI before treatment, 2-3 weeks after the initiation of CRT, and 4 weeks post-nCRT. The investigators will use advanced statistical tools to establish the model and further validate the model in another group of patients. The investigators will also establish a model for survival prediction.
- interventionNames
- Other: Biomarkers Testing
- Other: Functional Imaging analysis
Primary outcomes (1)
- measure
- Pathologic Response
- timeFrame
- Approximately 12 months
- description
- Mandard tumor regression grade (TRG) was used for pathology analysis. Primary tumor and positive lymph node regression were classified into five histologic tumor regression grades. Grade 1 (complete regression) showed absence of histologically identifiable residual cancer and fibrosis extending through the different layers of the esophageal wall, with or without granuloma. Grade 2 was characterized by the presence of rare residual cancer cells scattered through the fibrosis. Grade 3 involved an increase in the number of residual cancer cells, but fibrosis still predominated. Grade 4 showed residual cancer outgrowing fibrosis. Grade 5 was characterized by the absence of regressive changes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient must have histologic documentation of squamous carcinoma of the esophagus at Xijing Hospital. 2. Newly diagnosed Patients with localized carcinoma of the esophagus who have undergone standard testing and been evaluated by the multidisciplinary team at Xijing Hospital and are considered appropriate candidates for and are willing to undergo chemoradiotherapy followed by surgery at Xijing Hospital. 3. Patient must have undergone a baseline esophageal-gastroduodenoscopy (EGD) with biopsy and endoscopic ultrasonography at Xijing, with tissue available for biomarker analysis. 4. Patient must be willing to undergo this research and must provide written informed consent. Exclusion Criteria: 1. Patient is unable or unwilling to comply with the requirements of the protocol. 2. History of prior malignancy within the past 3 years. 3. Patients with second primary tumors. 4. Patients who received endoscopical therapy or induction chemotherapy prior to chemoradiation therapy are excluded. 5. Patient is not a candidate for chemoradiation followed by surgery.
References
Publications (0)
Data not yet available
No reference posted for this study.