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
159 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) continues to exhibit high incidence and mortality rates in China, with the majority of patients diagnosed at middle to advanced stages. Concurrent chemoradiotherapy (CCRT) is the standard treatment for unresectable locally advanced ESCC. The 5-year survival rate for advanced esophageal cancer remains below 20%. Immunotherapy has demonstrated definitive efficacy and a favorable toxicity profile in advanced ESCC, and preliminary results of its combination with radiotherapy have been reported. Induction immunochemotherapy followed by concurrent chemoradiotherapy represents a feasible combined treatment strategy. However, optimal biomarkers to identify patients who would benefit from this approach are still lacking. Circulating tumor DNA (ctDNA) status can accurately guide treatment implementation and predict tumor progression. Studies have shown that ctDNA changes precede imaging evidence of recurrence or metastasis, and ctDNA detection can sensitively predict tumor progression and prognosis. Therefore, it is necessary to dynamically monitor ctDNA changes throughout the course of induction immunochemotherapy followed by radical concurrent chemoradiotherapy in esophageal cancer and explore its correlation with prognosis.
CONDITIONS
Official 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 study procedures
- Aged 18 to 75 years
- Histologically or cytologically confirmed esophageal squamous cell carcinoma
- Clinical stage II-IVa, deemed inoperable by a surgeon or declined surgery
- No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer
- ECOG performance status of 0-1
- Laboratory tests before treatment meeting specific blood counts, liver, kidney, coagulation, and lipase levels
You will not qualify if you...
- Insufficient tissue or blood samples before treatment as required
- Refusal to undergo dynamic ctDNA testing
- Primary esophageal lesion too close to tracheobronchial tree or major blood vessels with high risk of perforation or bleeding
- History of other malignancies within 5 years except certain treated localized tumors
- Gastrointestinal bleeding within 6 months, coagulopathy, or current thrombolytic/anticoagulant therapy with high bleeding risk
- Severe cardiovascular or cerebrovascular diseases
- History of interstitial lung disease or active pneumonia or tuberculosis
- Severe allergic reactions to paclitaxel, cisplatin, or monoclonal antibodies
- Any condition deemed unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China, 321000
Actively Recruiting
2
The central Hospital of Lishui City
Lishui, Zhejiang, China, 323000
Actively Recruiting
Research Team
Z
Zhifeng Tian, MD
CONTACT
S
Shubo Ding, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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