Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

NCT05385926 | Recruiting Phase 2 DMC

• 1 other identifier: JS2022-35
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Nasopharyngeal Cancer

Keywords

Metastatic Nasopharyngeal Cancer; PD-1; Radiotherapy; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  1year

Secondary Outcomes (5)

• 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

  1 year

Study Arms (1)

RT group

EXPERIMENTAL

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

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.

RT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Shenzhen, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Li Ma, MD

CONTACT

+8675566618168; ml_1990@126.com

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: Head of Radiation Oncology

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: May 23, 2022
• Study Start: May 5, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)