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Induction Chemoimmunotherapy Followed by Deescalated Definitive Radiotherapy in Head and Neck Cancer
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
This study aims to evaluate whether reducing the intensity of radiotherapy (de-escalated radiotherapy) after induction chemoimmunotherapy is not inferior to standard-dose radiotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The study is a multicenter, prospective, phase II, randomized, non-inferiority controlled trial. A total of 180 participants who achieve deep tumor response (≥50% regression) after 2-3 cycles of induction chemotherapy plus PD-1 inhibitor (camrelizumab) will be randomized 1:1 to receive either de-escalated radiotherapy (experimental group) or standard radiotherapy (control group). Additional maintenance camrelizumab for 8 cycles after radiotherapy will be administered for both groups. The primary outcome is 2-year progression-free survival (PFS). Secondary outcomes include overall survival, local-regional control, distant metastasis-free survival, treatment-related adverse events, and quality of life. The study is expected to start in June 2026 and complete in December 2031.
Official title: Induction Chemoimmunotherapy Followed by Deescalated Definitive Radiotherapy (IDEAL-RT) in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Prospective, Phase II, Randomized Non-Inferiority Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-06-12
Completion Date
2032-12
Last Updated
2026-08-28
Healthy Volunteers
No
Interventions
Camrelizumab
Camrelizumab 200 mg IV every 3 weeks for 8 cycles after radiotherapy as maintenance.
Platinum-based Chemotherapy plus PD-1 inhibitor
Cisplatin or carboplatin based chemotherapy combined with PD-1 inhibitor for 2-3 cycles as induction therapy.
De-escalated Radiotherapy
Total dose 60 Gy to GTV (post-induction residual) in 25 fractions; CTV1 50 Gy/25 fractions; CTV2 45 Gy/25 fractions.
Standard Radiotherapy
Total dose 69.96 Gy to GTV (post-induction residual) in 33 fractions; CTV1 60.06 Gy/33 fractions; CTV2 50.96 Gy/28 fractions.
Locations (6)
Air Force Medical Center
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Harbin Medical University Cancer Hospital
Harbin, China
Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
Shenyang, China
Shanxi Cancer Hospital
Taiyuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China