Phase Ib/II Clinical Study of Neoadjuvant Carbon Ion Radiotherapy Combined with Immunotherapy for Head and Neck Squamous Cell Carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600129195

Enrollment

Unknown

Registered

2026-07-31

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

local advanced squamous cacinoma of head and neck

Interventions

experiment:Carbon radiation combined with PD-1 antibody

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed previously untreated head and neck squamous cell carcinoma (HNSCC), and investigators judge that subjects can safely receive neoadjuvant immunotherapy and carbon ion radiotherapy; 2. HPV status determined via p16 immunohistochemical staining; 3. Age ranging from 18 to 75 years old; 4. Capable of providing informed consent, complying with study protocol, and signing trial-specific informed consent documentation; 5. Zubrod performance status (ZPS) 0 or 1; 6. Adequate bone marrow, hepatic, renal, cardiac and pulmonary function to tolerate immunotherapy, surgery and radiotherapy.

Exclusion criteria

Exclusion criteria: 1. Patients with prior history of chemotherapy or previous radiotherapy to the head and neck region; 2. Patients with any other current malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma; 3. Patients with any uncontrolled clinical conditions, such as bleeding disorders, active infections, or psychiatric illnesses, which may interfere with safe study participation and protocol compliance; 4. Patients requiring long-term maintenance oral steroid therapy (>=20 mg prednisone equivalent daily), with the exception of those receiving inhaled, topical, or non-absorbable steroids; 5. Patients with a history of autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (including scleroderma and its variants), systemic lupus erythematosus, autoimmune vasculitis, and autoimmune neuropathy (e.g., Guillain-Barré syndrome).

Design outcomes

Primary

Measure	Time frame
Safety of carbon ion radiotherapy combined with PD-1 antibodies at the optimal dose;	—

Secondary

Measure	Time frame
Pathologic Complete Response Rate, pCR;Major pathological response rate, MPR;	—

Countries

China

Contacts

Public ContactJiang Feng

Zhejiang Cancer Hospital

jiangfeng@zjcc.org.cn+86 571 88128202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026