Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

Metastatic Nasopharyngeal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385926
• Other study ID #: JS2022-35
• Status: Recruiting
• Phase: Phase 2
• Start date: May 5, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Li Ma, MD
• Phone: +8675566618168
• Email: ml_1990[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)		1year
Secondary	Overall survival (OS)		1year
Secondary	Objective response rate (ORR)		4-8 weeks
Secondary	Local-regional free survival (LRFS)		1 year
Secondary	Distant metastasis free survival (DMFS)		1 year
Secondary	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