NCT07136519

Toripalimab, Induction Chemotherapy, Radiation Therapy With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma

Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma: A Phase II, Single Arm Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Affiliated Hospital of Guangdong Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy, adverse reactions, nutritional status analysis, and quality of life analysis of Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined with Omega-3 in the treatment of locally advanced nasopharyngeal carcinoma.

Detailed description

After being informed about the study and potential risks, all patients giving written informedconsent will undergo a 1-week screening period to determine eligibility for study entry. In week 0, eligible patients will be enrolled in a clinical study on the combination of Toripalimab, induction chemotherapy, sequential radiotherapy, and OMEGA-3 for the treatment of locally advanced nasopharyngeal carcinoma. Induction chemotherapy stage: Toripalimab 240mg d1, paclitaxel (albumin bound) 260mg/m2 d1, cisplatin 80mg/m2 d2 Q3W X 3 cycles. Radiotherapy stage: IMRT+Toripalimab 240mg Q3W X 3 cycles+Omega-3 (6 pills qd during radiotherapy). IMRT：GTVnx 69.96Gy，GTVnd 69.96Gy，CTV1 60Gy，CTV2 54Gy。 Maintenance treatment: Toripalimab 240mg Q3W X 6 cycles.

Conditions

• Nasopharyngeal Carcinoma (NPC)

Interventions

Type	Name	Description
DRUG	Toripalimab	240mg Q3W
DIETARY_SUPPLEMENT	Omega-3	During radiotherapy, take 6 capsules once a day
RADIATION	radiotherapy	radiotherapy
DRUG	Paclitaxel (albumin bound)	260mg/m2 d1,Q3W
DRUG	Cisplatin	80mg/m2 d2, Q3W

Timeline

• Start date: 2025-08-22
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2025-08-22
• Last updated: 2025-08-22