Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC
Low-Dose Involved-Field Radiotherapy Combined with Immunochemotherapy for Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma: a Prospective, Single-Arm, Phase II Study.
Sichuan University
41 participants
Aug 24, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- Age 18-80 years
- Patients with locally advanced, unresectable ESCC who have received radical treatment (radical chemoradiotherapy or radical radiochemotherapy), including:
- Cervical esophagus involvement, T4 stage, supraclavicular lymph node metastasis, or inability to tolerate or refusal of surgery due to personal reasons; Failure of neoadjuvant or conversion therapy;Unresectable local recurrence after surgery (with measurable target lesions)
- No evidence of tumor recurrence or metastasis on follow-up examination 2-3 weeks after radical treatment
- Ability to provide fresh tumor tissue specimens (baseline)
- Normal function of major organs
- Performance Status (PS) score ≤ 1
- Patients of childbearing potential must agree to use contraception.
- Voluntary participation with signed informed consent
Exclusion Criteria10
- History of fistula formation due to primary tumor invasion
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
- Poor nutritional status
- Previous immune-related adverse events during prior radical treatment, including grade ≥3 immune-related pneumonitis, myocarditis, etc
- Presence of symptoms or signs of interstitial disease
- Patients with any severe and/or uncontrolled medical condition
- Presence of concurrent malignancies
- Presence of other autoimmune diseases or long-term use of immunosuppressants or corticosteroids.
- Patients who are difficult to communicate with or are unlikely to comply with long-term follow-up.
- Any other conditions that the investigator deems unsuitable for participation.
Interventions
low-dose involved-field radiotherapy combined with immunochemotherapy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06603402