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Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC

RECRUITINGPhase 2Sponsored by Sichuan University
Actively Recruiting
PhasePhase 2
SponsorSichuan University
Started2023-08-24
Est. completion2025-03-01
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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.

Conditions3

CancerEsophageal Squamous Cell Carcinoma (ESCC)Immunotherapy

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