Actively Recruiting
A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring
Led by The Central Hospital of Lishui City · Updated on 2026-03-23
30
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
T
The Central Hospital of Lishui City
Lead Sponsor
A
Affiliated Hospital of Jiaxing University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Esophageal squamous cell carcinoma ESCC is a common and deadly cancer in China, with many patients diagnosed at advanced stages. This study evaluates a combined treatment approach using induction immunochemotherapy followed by concurrent chemoradiotherapy, aiming to improve outcomes for patients with locally advanced, unresectable ESCC. Researchers also focus on using circulating tumor DNA ctDNA to monitor treatment response and predict tumor progression, as ctDNA changes can appear before imaging detects recurrence. Participants receive induction immunochemotherapy consisting of toripalimab combined with paclitaxel and cisplatin every three weeks for two cycles. This is followed by radical concurrent chemoradiotherapy with weekly paclitaxel and cisplatin for five cycles along with radiotherapy delivered five days per week. The study dynamically monitors ctDNA levels at several points before treatment, before chemoradiotherapy, after 20 radiotherapy fractions, and every three months after treatment completion. During the study, participants undergo regular assessments including blood tests for ctDNA analysis and monitoring of tumor status. The main outcome measured is progression-free survival at one year. Safety and efficacy are tracked throughout the treatment and follow-up periods. The total participation duration and timing of assessments are carefully planned to evaluate the treatment strategy and its correlation with patient prognosis.
CONDITIONS
Brief Title
A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age between 18 and 75 years
- Histologically or cytologically confirmed esophageal squamous cell carcinoma
- Clinical stage II-IVa, assessed as inoperable or patient refusal of surgery
- No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer
- ECOG performance status of 0 or 1
- Laboratory values within specified limits for blood counts, liver, kidney function, and coagulation before first treatment dose
You will not qualify if you...
- Insufficient tissue or blood samples available before treatment as required
- Refusal to undergo dynamic ctDNA testing
- Primary esophageal lesion close to major blood vessels or tracheobronchial tree with high risk of perforation or bleeding
- History of other cancers within 5 years except certain localized tumors
- History of gastrointestinal bleeding within 6 months or coagulation disorders or current blood thinning therapy
- Severe cardiovascular or cerebrovascular diseases
- History of interstitial lung disease or active lung infections
- Severe allergic reactions to paclitaxel, cisplatin, or monoclonal antibodies
- Any other condition that makes participation inappropriate as judged by the investigator
Research Team
Z
Zhifeng Tian, MD
S
Shubo Ding, MD
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