At a glance
ClinicalIndex Comparison Record- ✓Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx)
- ✓Stage T3-4N0M0 or T1-4N1-3M0, III-IVB according to AJCC 8th edition
- ✓Eligible for radical surgery as judged by surgeons
- ✓Age 18-70 years
- ✕Pregnant or lactating women
- ✕History of allergies to PD-1 inhibitors, albumin-bound paclitaxel, or cisplatin
- ✕Other malignant tumors within previous 5 years (except basal cell carcinoma, cervical in situ cancer, thyroid papilloma)
- ✕Uncontrolled cardiac disease: NYHA class II+ heart failure, unstable angina, MI within 1 year, or clinically significant arrhythmias
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05343325Phase 2RecruitingUpdate OverdueUpdated 42mo ago · Completion was 27mo agoNeoadjuvant Low-dose Radiotherapy, Tislelizumab, Combined With Albumin-bound Paclitaxel and Cisplatin in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (NeoRTPC02): an Open Label, Single-arm, Phase II Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Tislelizumab and Low-dose radiotherapy for Head and Neck Squamous Cell Carcinoma and Neoadjuvant Treatment. Currently recruiting, targeting 25 participants across 2 sites.
Signals
Detailed Summary
This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of neoadjuvant low-dose radiotherapy combined with chemoimmunotherapy in resectable locally advanced head and neck squamous cell carcinoma. The eligible patients are scheduled to administered neoadjuvant low-dose radiotherapy, tislelizumab, combined with albumin-bound paclitaxel and cisplatin for two cycles. Radical resection will be performed in 3-4 weeks after two cycles of neoadjuvant therapy. The overall primary study hypothesis is that the novel neoadjuvant combination regime improves the pathological complete response (pCR) rate, with tolerable side effects.
Study Details
Timeline
Interventions
Tislelizumab: 200 mg D1, Q3W for two cycles. Albumin-bound paclitaxel: 100mg/m2, D1, D8, D15, Q3W for two cycles. Cisplatin: 25mg/m2, D1, D8, D15, Q3W for two cycles.
Low-dose radiotherapy: 1GY/1F, D1, D2, D8, D15, Q3W for two cycles. The total radiation dose will be GTV 8Gy/8F, GTVnd 8 Gy/8F.