NCT06861712

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

Neoadjuvant Chemoimmunotherapy With or Without SBRT Followed by Surgery for Locoregionally Advanced Squamous Cell Carcinoma of the Oral Cavity and Oropharynx: A Phase II Randomized Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

In this study, participants will be randomly assigned to either the experimental group or the control group. The experimental group will first receive SBRT (6Gy\*3 fractions) to treat the primary tumor and metastatic lymph nodes. This will be followed by a combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks. The control group will receive the same combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks, but without SBRT. After the final round of chemotherapy, all participants will have imaging scans and, three weeks later, undergo surgery. After surgery, they may also receive additional radiotherapy with or without chemotherapy. Patients can also choose whether to continue treatment with Toripalimab after surgery.

Detailed description

Participants will be randomly assigned to the experimental group and the control group. 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). One to two weeks after SBRT, they will receive 240 mg of Toripalimab + 75 mg/m² of Docetaxel + 75 mg/m² of Cisplatin, administered every 3 weeks for 3 cycles. The control group will receive 240 mg of Toripalimab + 75 mg/m² of Docetaxel + 75 mg/m² of Cisplatin, administered every 3 weeks for 3 cycles. Both groups will undergo imaging assessment 2 weeks after the final chemotherapy cycle. Three weeks after the last chemotherapy cycle, participants will receive curative surgery. Postoperative adjuvant radiotherapy ± chemotherapy will be administered according to preoperative staging and postoperative pathological characteristics. Patients may also choose to continue maintenance treatment with Toripalimab after surgery.

Conditions

• Oral Squamous Cell Carcinoma (OSCC)
• Oropharyngeal Squamous Cell Carcinoma (SCC)
• Stereotactic Body Radiation Therapy (SBRT)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-06
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-03-06
• Last updated: 2025-04-25

Locations

1 site across 1 country: China