Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

A Phase II Study: Safety and Efficacy of Combining Radiation Therapy With Immunotherapy and Chemotherapy in de Novo Metastatic Nasopharyngeal Carcinoma

Incidences of de novo metastatic nasopharyngeal carcinoma range from 6% to 8% at the time of presentation. For the initial diagnosis of metastatic NPC, PD-1 plus chemotherapy yields a satisfactory outcome with1year PFS of 40%. Previous study demonstrated the benefit of adding radiotherapy to chemotherapy in metastatic NPC, however there is no evidence whether radiotherapy can further improve PFS based on chemotherapy plus PD-1 . The purpose of this study is to evaluate the safety and effectiveness of first-line immunochemotherapy combined with radiotherapy for initial diagnosed metastatic NPC.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Nasopharyngeal Cancer
• Intervention / Treatment: Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Li Ma, MD; Phone Number: +8675566618168; Email: ml_1990@126.com

Study Locations

• China
  • Shenzhen, China
    • Recruiting
    • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: Li Ma, MD; Phone Number: +8675566618168; Email: ml_1990@126.com
    • Principal Investigator: Runye Wu, PhD
    • Principal Investigator: Li Ma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age:18-75 years, male or female.
• ECOG 0-2
• Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma.(stage IVb, AJCC 8th)
• Complete response or partial response after at least 3 cycles (no more than 6 cycles) of chemotherapy combined with immunotherapy
• Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
• Adequate organ function.
• Patient has given written informed consent.

Exclusion Criteria:

• Unwilling or unable to provide informed consent
• Intolerance to radiotherapy or immunotherapy
• Patients who have head and neck radiotherapy history.
• previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
• women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
• in other clinical trials within 30 days
• Patients with autoimmune disorder, including but not limited to systemic lupus erythematosus or multiple sclerosis;
• History of primary immunodeficiency
• History of active tuberculosis, drug-induced interstitial lung disease, or ≥ Grade 2 pulmonitis;
• Patients with human immunodeficiency virus (HIV) positive;
• Comorbidities that cannot be controlled by concomitant treatment, including but not limited to: ongoing or active infection, unexplained fever > 38.5°C (subjects with neoplastic fever are judged by the investigator to be included), symptomatic congestive heart failure ≥ Grade 2 according to New York Heart Association (NYHA) functional classification, LVEF (left ventricular ejection fraction) < 50%, hypertension poorly controlled by drugs, unstable angina, arrhythmia, active peptic ulcer disease or gastritis;
• not suitable for this study judged by researchers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RT group	Radiation: Radiotherapy; Patients who had complete response or partial response after at least 3 cycles (no more than 6 cycles) of chemotherapy combined with immunotherapy receive local radiotherapy 21 days. For those non-CR oligo-metastatic disease or symptomatic lesion, SBRT or conventional RT delivered. Maintenance therapy of immunotherapy for 2 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival (PFS)	1year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)		1year
Objective response rate (ORR)		4-8 weeks
Local-regional free survival (LRFS)		1 year
Distant metastasis free survival (DMFS)		1 year
Treatment-emergent adverse events	Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 5.0 (CTCAE v5.0)	1 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: May 14, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; Chemotherapy; PD-1; Metastatic Nasopharyngeal Cancer
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
• Other Study ID Numbers: JS2022-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No