Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC

Recruiting now · Phase 2

Conditions studied: Esophageal Squamous Cell Carcinoma (ESCC), Immunotherapy

In brief

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.

Key facts

Study ID

NCT06603402

Run by

Sichuan University

People needed

41

Starts

2023-08-24

Expected to finish

2025-09-01

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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