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Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab in the De Novo Metastatic Nasopharyngeal Carcinoma

NCT04398056 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-07-06

No results posted yet for this study

Summary

The purpose of this study is to preliminarily evaluate the efficacy and safety of chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab for the de novo metastatic nasopharyngeal carcinoma.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Chemotherapy plus radiotherapy and Toripalimab

1. Chemotherapy: The PF regimen included 5 g/m2 5-fluorouracil via a continuous intravenous infusion over 120 h and an intravenous administration of 100 mg/m2 cisplatin on day 1 for a maximum of six cycles. 2. Radiotherapy, intensity-modulated radiation therapy (IMRT), PTVnx:66-70Gy/30-33F; PTVnd:66～70Gy/30～33F; PTV1:60～64Gy/30～33F; PTV2:50～54Gy/30～33F, 5 fractions per week, for 6 weeks 3. Toripalimab 240mg every three weeks (Q3W) began on the first day of radiotherapy until an intolerable toxicity, or disease progression, or withdrawal of consent, or the investigator determines that he or she has to withdraw from treatment, or has been treated for up to 2 years.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming-Yuan Chen, PhD · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-07-01
Completion
2024-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04398056 on ClinicalTrials.gov