drugset / Trial / NCT06470217
Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma
Phase 2
Recruiting
116 enrolled
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
RandomizedParallel-groupOpen-labelTreatment
Summary
The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed. Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.
Timeline
- Start
- 2024-06-19
- Primary completion
- 2025-06-19
- Completion
- 2027-06-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 260 mg/m2 | — |
| Subject | tirilizumab | Unknown | 200 mg | Intravenous |