RecruitingPhase 1Phase 2NCT06572514

De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC

The Exploratory Study of the Feasibility of De-escalating Radiation Strategy After NAC in Combination With Immunotherapy in LAHNSCC

Sponsor

Ruijin Hospital

Enrollment

20 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Summary

This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Three months after the completion of radiotherapy, a follow-up examination was conducted, and salvage surgery or systemic therapy was performed as necessary based on the follow-up results.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with locally advanced head and neck cancer who respond very well to a combination of chemotherapy and immunotherapy before radiation can safely receive a lower radiation dose — potentially reducing side effects while maintaining cancer control. **You may be eligible if...** - You are 18 or older - You have been diagnosed with oral, throat (oropharyngeal), laryngeal, or hypopharyngeal cancer - Your cancer has not spread to distant organs - You have a good performance status (ECOG 0–1) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body - You are not well enough to undergo treatment - You have poor kidney, liver, or blood function that doesn't meet the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGimmunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin

The immunotherapy drug was pembrolizumab at a dose of 200 mg, administered on the first day of each cycle every 3 weeks. The induction chemotherapy regimen included albumin-bound paclitaxel at 260 mg/m2 and cisplatin at 75 mg/m2, given every 3 weeks, either concurrently with immunotherapy or on the second day.

Locations(1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT06572514

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