Status:
UNKNOWN
Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab in the De Novo Metastatic Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 nasophary...
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 torip...
Eligibility Criteria
Inclusion
- 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
- 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:
- congestive heart failure (New York Health Authority Class \> 2);
- unstable angina;
- myocardial infarction within the past 12 months;
- clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
- Active infection or an unexplained fever; 38.5℃ during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled);
- History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease;
- Any other medical (eg, pulmonary, metabolic, congenital, endocrinal, or CNS disease), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results;
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation based on institutional guidelines and tests. Testing may include the following: HBV DNA, HCV RNA, hepatitis B surface antigen, or anti-Hepatitis B core antibody.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04398056
Start Date
April 1 2019
End Date
July 1 2024
Last Update
July 6 2022
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, China