Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC

Sponsor
Chen Chunyan
Study ID
NCT07554768
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    A humanized IgG4 monoclonal antibody against programmed cell death-ligand 1 (PD-L1). Dosage: 1200 mg administered via intravenous (IV) infusion on Day 1 of each 21-day cycle, for a total of 2 cycles in the neoadjuvant setting.
  • radiotherapy — RADIATION
    Neoadjuvant radiotherapy targeting the primary tumor and involved cervical lymph nodes. (SBRT with a total dose of \[24\] Gy in \[3\] fractions).

Study Details

The purpose of this randomized Phase II study is to evaluate and compare the efficacy and safety of neoadjuvant radio-immunotherapy versus immunotherapy alone for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Participants will be randomly assigned to one of two groups. The experimental group will receive a combination of radiotherapy and Adebrelimab as neoadjuvant treatment, while the control group will receive Adebrelimab monotherapy. Following the neoadjuvant phase, all eligible patients will undergo surgical resection. The primary objective is to determine if the addition of radiotherapy improves the major pathological response (MPR) rate. Secondary objectives include pathological complete response (pCR) rate, objective response rate (ORR), and event-free survival (EFS).

Key Dates

First listed
Apr 28, 2026
Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
May 1, 2028
Completion
May 1, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Radio-immunotherapy (Adebrelimab + RT)
    Patients will receive 2 cycles of neoadjuvant Adebrelimab (1200 mg, IV, Q3W) combined with radiotherapy (SBRT), followed by surgical resection.
  • Active Comparator: Neoadjuvant Immunotherapy Monotherapy (Adebrelimab)
    Patients will receive 2 cycles of neoadjuvant Adebrelimab (1200 mg, IV, Q3W) monotherapy, followed by surgical resection.

Primary Outcome Measure

Major Pathological Response (MPR) Rate [ Time Frame: At the time of surgery (approximately 6-8 weeks after the first dose of neoadjuvant therapy). ]

Central Contacts

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