Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low-dose involved-field radiotherapy combined with immunochemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- low-dose involved-field radiotherapy combined with immunochemotherapy
- description
- low-dose involved-field radiotherapy combined with immunochemotherapy
- interventionNames
- Radiation: low-dose involved-field radiotherapy combined with immunochemotherapy
Primary outcomes (1)
- measure
- The safety of low-dose involved-field radiotherapy combined with immunochemotherapy
- timeFrame
- 12months
- description
- This study will collected any adverse medical events that occurred during the study drug treatment, and the treatment-related adverse events as assessed by\" CTCAE v5.0\".
Secondary outcomes (3)
- measure
- The efficacy of low-dose involved-field radiotherapy combined with immunochemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available