Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngeal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 6, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Oral Squamous Cell Carcinoma (OSCC)Oropharyngeal Squamous Cell Carcinoma (SCC)Stereotactic Body Radiation Therapy (SBRT)
Interventions
RADIATION

SBRT

The experimental group will first receive SBRT (Stereotactic Body Radiotherapy) for the primary tumor and positive lymph nodes (prescribed dose: 6 Gy × 3 fractions, once every other day).

DRUG

Docetaxel, Cisplatin, Toripalimab

Toripalimab 240mg (free medicine) + Docetaxel 75mg/m2 + Cisplatin 75mg/m2, q3w for 3 courses

PROCEDURE

Radical resection surgery

Radical resection surgery

RADIATION

IMRT ± chemotherapy/toripalimab

According to the preoperative staging and postoperative pathological characteristics, all patients will receive postoperative radiotherapy with or without cisplatin-based chemotherapy. Additionally, patients can choose whether to continue maintenance therapy with toripalimab after surgery.

Trial Locations (1)

510050

Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

Hospital of Stomatology, Sun Yat-Sen University

OTHER

lead

Sun Yat-sen University

OTHER