NCT06603402 Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC
| NCT ID | NCT06603402 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sichuan University |
| Condition | Esophageal Squamous Cell Carcinoma (ESCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2023-08-24 |
| Primary Completion | 2025-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 41 participants in total. It began in 2023-08-24 with a primary completion date of 2025-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
zhenyu ding, MD
PRINCIPAL INVESTIGATOR
West China Hospital, Sichuan University, China
Frequently Asked Questions
Who can join the NCT06603402 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Esophageal Squamous Cell Carcinoma (ESCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06603402 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06603402 currently recruiting?
Yes, NCT06603402 is actively recruiting participants. Contact the research team at dingzhenyu@scu.edu.cn for enrollment information.
Where is the NCT06603402 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT06603402 clinical trial?
NCT06603402 is sponsored by Sichuan University. The principal investigator is zhenyu ding, MD at West China Hospital, Sichuan University, China. The trial plans to enroll 41 participants.