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Clinical Trials in China / NCT07791602
Active, not recruiting Phase 2

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

NCT07791602 · tracked via the Priya Life Science China tracker
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Phase
Phase 2
Started
2026-06-12
Last updated
2026-08-28

Condition(s) studied

Head and Neck Squamous Cell CarcinomaLocally Advanced Head and Neck CancerHNSCC

Investigational drug(s) / intervention(s)

CamrelizumabPlatinum-based Chemotherapy plus PD-1 inhibitorDe-escalated RadiotherapyStandard Radiotherapy

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with head and neck squamous cell carcinoma (HNSCC) who have completed 2-3 cycles of induction chemotherapy plus PD-1 inhibitor and achieved deep response. 2. Within 1 month of achieving deep response, subsequent concurrent chemoradiotherapy is determined by integrating MDT recommendation and patient's discretion. 2\. Age 18 to 75 years (including 75). 3. Histopathologically confirmed HNSCC (excluding nasopharyngeal carcinoma). 4. Clinical stage T1-2N2-3M0 or T3-4N0-3M0 (AJCC 8th edition). 5. HPV or P16 negative. 6. ECOG performance status 0 or 1. 7. No contraindications to immunotherapy or radiotherapy. 8. Adequate organ function as defined by: * WBC ≥ 3.0×10\^9/L, ANC ≥ 2.0×10\^9/L, PLT ≥ 100×10\^9/L, HGB ≥ 90 g/L (no transfusion or G-CSF within 14 days). * TBIL ≤ 2.0×ULN, ALT/AST ≤ 2.5×ULN, BUN/CRE ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min. * INR or PT ≤ 1.5×ULN (or within therapeutic range for anticoagulation). * Myocardial enzymes within normal limits. 9. For women of childbearing potential: negative pregnancy test within 7 days prior to enrollment and use of effective contraception during treatment and for 2 months after last dose. Male participants must agree to use effective contraception for the same period. 10\. Willing to sign informed consent and comply with follow-up. Exclusion Criteria: 1. Occurrence of ≥ G4 toxicities during induction therapy and not suitable to receiving subsequent concurrent chemoradiotherapy or immunotherapy. 2. History of another active malignancy within 5 years, except cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, or superficial bladder cancer. 3. Active or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism/hypothyroidism requiring hormone replacement). Exceptions: vitiligo, childhood asthma fully resolved without intervention; asthma requiring bronchodilator medical intervention is excluded. 4. Uncontrolled cardiovascular disease: myocardial ischemia grade II or higher, myocardial infarction, poorly controlled arrhythmia (including QTc ≥ 470 ms), NYHA class III-IV heart failure, LVEF \< 50%, or myocardial infarction within 1 year. 5. Active infection or unexplained fever \>38.5°C during screening (tumor fever allowed if judged by investigator). 6. Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10\^4 copies/mL), or active hepatitis C (HCV-RNA above lower limit of detection). 7. Prior treatment with any PD-1/PD-L1 inhibitor. 8. Allergy to cisplatin, macromolecular protein preparations, or any component of anti-PD-1 antibodies. 9. Major surgery for non-tumor reasons without full recovery of toxicity/complications before starting study treatment. 10. Pregnancy or breastfeeding. 11. Any other condition that, in the investigator's judgment, would interfere with study participation or data collection (e.g., severe psychiatric illness, abnormal laboratory values, family or social factors).

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
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

More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07791602 on ClinicalTrials.gov ↗ ← All trials in China