Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07791602
PHASE2

Induction Chemoimmunotherapy Followed by Deescalated Definitive Radiotherapy in Head and Neck Cancer

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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

DRUG

Camrelizumab

Camrelizumab 200 mg IV every 3 weeks for 8 cycles after radiotherapy as maintenance.

DRUG

Platinum-based Chemotherapy plus PD-1 inhibitor

Cisplatin or carboplatin based chemotherapy combined with PD-1 inhibitor for 2-3 cycles as induction therapy.

RADIATION

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.

RADIATION

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