Actively Recruiting
Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC
Led by Sichuan University · Updated on 2024-12-03
41
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this clinical trial is to evaluate whether low-dose involved-field radiotherapy combined with immunochemotherapy can reduce treatment-related adverse effects, enhance progression-free survival (PFS), and improve overall survival (OS) in patients with locally advanced, unresectable esophageal squamous cell carcinoma. The key questions this study seeks to address are: * Can low-dose involved-field radiotherapy combined with immunochemotherapy reduce treatment-related adverse effects? * Does this combined approach improve PFS and OS in these patients? Participants in the study will: * Undergo an endoscopy at West China Hospital to confirm their diagnosis. * Receive a treatment regimen that includes low-dose radiotherapy at 45.0 Gy in 1.8 Gy per fraction over 25 fractions, alongside immunochemotherapy, with three cycles of chemotherapy administered every 3 weeks. * After completing the full treatment regimen, participants will undergo regular follow-up visits and monitoring by healthcare professionals.
CONDITIONS
Official Title
Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Locally advanced, unresectable esophageal squamous cell carcinoma (ESCC) patients who have received radical treatment including chemoradiotherapy or radiochemotherapy
- Includes patients with cervical esophagus involvement, T4 stage, supraclavicular lymph node metastasis, or those unable or refusing surgery
- Failure of neoadjuvant or conversion therapy
- Unresectable local recurrence after surgery with measurable target lesions
- No tumor recurrence or metastasis 2-3 weeks after radical treatment on follow-up
- Ability to provide fresh tumor tissue specimens
- Normal major organ function
- Performance Status score 1 or less
- Agreement to use contraception if of childbearing potential
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of fistula formation due to primary tumor invasion
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation
- Poor nutritional status
- Previous severe immune-related adverse events during prior radical treatment
- Symptoms or signs of interstitial disease
- Severe or uncontrolled medical conditions
- Presence of other cancers
- Other autoimmune diseases or long-term use of immunosuppressants or corticosteroids
- Difficulties in communication or unlikely to comply with long-term follow-up
- Any other conditions that investigators consider unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Z
zhenyu ding, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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