Status:
RECRUITING
Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC
Lead Sponsor:
Sichuan University
Conditions:
Esophageal Squamous Cell Carcinoma (ESCC)
Immunotherapy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 survi...
Detailed Description
This is a single-arm, single-center, prospective clinical study aimed at evaluating the efficacy and safety of low-dose involved-field radiotherapy combined with immunochemotherapy in patients with lo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06603402
Start Date
August 24 2023
End Date
September 1 2025
Last Update
December 3 2024
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041