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RECRUITING
NCT05290194
PHASE2

Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma

Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

This is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma.

Official title: Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2022-03-28

Completion Date

2027-01-01

Last Updated

2022-04-14

Healthy Volunteers

No

Interventions

RADIATION

SBRT radiotherapy + Conventionally fractionated radiotherapy

Radiotherapy was performed 3-6 weeks after the end of first-line treatment, followed by conventional fractionated radiotherapy of the primary tumor and cervical lymph node metastases, SBRT radiotherapy of distant organ metastases 3-6 weeks later.

DRUG

PD-1 inhibitor

Immunotherapy of PD-1 inhibitor is used during the whole time of this trial until subjects were withdrawn from the trial or the trial complete

DRUG

Capecitabine

Capecitabine is treated for patients 3-6 weeks after radiotherapy, which combines with PD-1 inhibitor as the maintenance regimen in the trial.

Locations (1)

Fifth Affilliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China