Assessing tumor response to predict post-surgery treatment in esophageal cancer
Tumor Regression Grade As Predictor of Adjuvant Therapy Benefits in Patients with Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy
This study is testing if the way tumors shrink after treatment can help doctors decide the best follow-up care for patients with esophageal cancer after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06710665 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of tumor regression grade (TRG) in predicting the effectiveness of adjuvant therapy for patients with esophageal squamous cell carcinoma (ESCC) who have undergone neoadjuvant therapy followed by surgery. Patients will be categorized based on their TRG scores into good responders and poor responders, and their overall survival will be monitored. The study aims to clarify the relationship between TRG and the necessity of adjuvant therapy, utilizing Cox proportional hazards regression models to analyze survival outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with locally advanced esophageal squamous cell carcinoma who have undergone R0 resection after neoadjuvant therapy.
Not a fit: Patients with incomplete clinical data or those diagnosed with multiple primary malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor postoperative treatment plans for ESCC patients, potentially improving survival rates.
How similar studies have performed: While the role of TRG in predicting outcomes has been explored in other cancers, its specific application in guiding adjuvant therapy for ESCC remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (I) underwent R0 resection with either two-field or three-field lymphadenectomy (II) received neoadjuvant therapy such as preoperative radiotherapy, chemoradiotherapy, or combined immunotherapy (III) had esophageal squamous cell carcinoma pathology. Exclusion Criteria: (I) Patients with incomplete clinical data or follow-up information (II) Diagnosed with multiple primary malignancies
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Maohui Chen
- Email: 757860733@qq.com
- Phone: 18659181171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.