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RECRUITING
NCT06323239
PHASE2

SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.

Official title: Stereotactic Body Radiotherapy (SBRT) and Low-dose Radiotherapy (LDRT) Combined With Programmed Death 1 (PD-1) Antibody and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Single-arm, Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2024-07-15

Completion Date

2028-07-01

Last Updated

2024-08-20

Healthy Volunteers

No

Interventions

RADIATION

SBRT

SBRT for metastatic lesions

RADIATION

Low-dose Radiotherapy (LDRT)

LDRT for metastatic lesions

DRUG

Toripalimab

6 cycles for combined therapy. Toripalimab maintenance for 1 year.

DRUG

Gemcitabine

6 cycles for combined therapy.

DRUG

Cisplatin

6 cycles for combined therapy.

RADIATION

IMRT

IMRT for primary lesion

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China