CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 22 enrolled
Drug / intervention
Chemotherapy plus radiotherapy and Toripalimabdrug
Likely dose
Chemotherapy plus radiotherapy and Toripalimab 5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04398056
NCT04398056Phase 2Unknown
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Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab for the de Novo Metastatic Nasopharyngeal Carcinoma: a Single Center, Phase II Clinical Trial.

Sun Yat-sen University·interventional·Posted May 21, 2020·Updated Jul 6, 2022

In Brief

A Phase 2 clinical trial evaluating Chemotherapy plus radiotherapy and Toripalimab for Nasopharyngeal Carcinoma. Targeting 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasopharyngeal Carcinoma
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
2020202120222023202420252026
First PostedMay 21, 2020
Enrollment StartApr 1, 2019
Primary CompletionJul 1, 2022
Study CompletionJul 1, 2024
TodayJul 1, 2026
Enrollment to primary: 3.3 yearsPosted 6.1 years ago

Interventions

Chemotherapy plus radiotherapy and Toripalimabdrug

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.