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 University1 site in 1 country22 target enrollmentApril 1, 2019

ConditionsNasopharyngeal Carcinoma

InterventionsChemotherapy plus radiotherapy and Toripalimab

DrugsChemotherapy plus radiotherapy and Toripalimab

Overview

Phase: Phase 2
Intervention: Chemotherapy plus radiotherapy and Toripalimab
Conditions: Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 22
Locations: 1
Primary Endpoint: Objective Response Rate
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

This is a single center , single arm, phase II study. All eligible patients with the de novo metastatic NPC are treated with chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab. The primary objective of this study is to assess objective response rate of chemotherapy plus subsequent loco-regional radiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma . The secondary objective is to assess progression free survival, and Adverse events.

Registry

clinicaltrials.gov

Start Date

April 1, 2019

End Date

July 1, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Ming-Yuan Chen

professor & chief physician

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Had histopathologically confirmed metastatic NPC that was diagnosed as stage IVb NPC as defined by the AJCC, 8th edition;
•Patients evaluated to have a complete response (CR) or partial response (PR) by an imaging study after three cycles of cisplatin plus 5-fluorouracil (PF) chemotherapy;
•Patients who did not receive any previous systemic chemotherapy;
•Patients with a Karnofsky performance status (KPS) score of at least 70;
•Patients with adequate organ function (white blood cell count of at least 4.0x109 per L; absolute neutrophil of at least 2.0x109 per L; hemoglobin concentrations of at least 90 g/L; platelet cell count of at least 100 x109 per L; aspartate transaminase and alanine transaminase levels less than 2.5 times the upper limit of the normal value; and creatinine clearance rate of at least 60 mL/min);
•Patients who provided written informed consent;
•Patients who agree to regular follow-up visits.

Exclusion Criteria

•Patients with recurrent mNPC who received prior definitive radiotherapy/chemoradiotherapy;
•Patients with life-threatening medical disorders;
•Patients who were pregnant or breastfeeding;
•Patients with other invasive malignant diseases within the past 5 years, other than excised basal-cell skin carcinoma, cervical carcinoma in situ, superficial bladder tumors (Ta, Tis, and T1);
•Patients with serious comorbidities.
•Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval;
•Known history of hypersensitivity to any components of the Toripalimab formulation;
•Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed;
•Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease);
•Uncontrolled clinically significant medical condition, including but not limited to the following:

Arms & Interventions

Chemotherapy plus radiotherapy and Toripalimab

Patients were treated with PF chemotherapy for a maximum of six cycles followed by loco-regional radiotherapy combined with toripalimab.

Intervention: Chemotherapy plus radiotherapy and Toripalimab

Outcomes

Primary Outcomes

Objective Response Rate

Time Frame: 1 year

The proportion of patients who achieved an objective response, defined as those with radiologically confirmed complete or partial response according to RECIST 1.1 assessed by the investigator;