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Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma

NCT04453813 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2020-09-28

No results posted yet for this study

Summary

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy alone.

Conditions

  • Nasopharyngeal Carcinoma
  • Chemotherapy
  • Radiotherapy
  • PD-1 Treatment

Interventions

DRUG

Toripalimab plus concurrent chemo-radiotherapy

1. Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of toripalimab are concurrently used during radiotherapy and other 9 cycles of toripalimab are used after the end of radiotherapy. (A total of 11 cycles). 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy

DRUG

Concurrent chemo-radiotherapy

1. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 2. IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy

Sponsors & Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    collaborator OTHER

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Yuebei People's Hospital

    collaborator OTHER

  • Wuzhou Red Cross Hospital

    collaborator OTHER

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-03
Primary Completion
2025-07-31
Completion
2027-07-31

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 NCT04453813 on ClinicalTrials.gov