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

NCT04398056 | Unknown Phase 2 DMC

• 1 other identifier: SYSUCC2019
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

de novo nasopharyngeal carcinoma; radiotherapy; PD-1

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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;

  1 year

Secondary Outcomes (3)

• Disease Control Rate

  1 year

• Progression-free survival

  1 year

• The toxicity grade will be assessed according to CTCAE 5.0.

  1 year

Study Arms (1)

Chemotherapy plus radiotherapy and Toripalimab

EXPERIMENTAL

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

Drug: Chemotherapy plus radiotherapy and Toripalimab

Interventions

Chemotherapy plus radiotherapy and Toripalimab DRUG

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.

Chemotherapy plus radiotherapy and Toripalimab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

Related Publications (1)

• Chen SY, Duan XT, Li HF, Peng L, Wang ZQ, Xu GQ, Hua YJ, Zou X, You R, Ouyang YF, Liu YP, Gu CM, Yang Q, Jiang R, Zhang MX, Lin M, Xie YL, Lin C, Ding X, Xie RQ, Duan CY, Zhang WJ, Huang PY, Chen MY. Efficacy of sequential chemoradiotherapy combined with toripalimab in de novo metastatic nasopharyngeal carcinoma: A phase II trial. Cell Rep Med. 2023 Nov 21;4(11):101279. doi: 10.1016/j.xcrm.2023.101279. Epub 2023 Nov 10.

  PMID: 37951218 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Drug Therapy; Radiotherapy; toripalimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ming-Yuan Chen, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor & chief physician

Model Details: This study used Simon's two-stage design. The main purpose of the study was to determine the objective response rates (PR+CR) of local-regional radiotherapy combined with Toripalimab followed by systemic chemotherapy for de novo metastatic nasopharyngeal carcinoma.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 21, 2020
• Study Start: April 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2024
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)