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SBRT Combined With Chemotherapy and Tislelizumab in Metastatic NPC

Primary Purpose

Advanced Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SBRT
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed a written informed consent form (ICF) voluntarily. Male or female, aged from 18 to 75 years. Pathologically confirmed newly diagnosed or treated metastatic patients are not suitable for radiotherapy. Have not received treatment for metastatic nasopharyngeal carcinoma. At least one metastatic lesion can be treated with SBRT. ECOG score 0-1. Expected survival expectancy of no less than 6 months. Adequate bone marrow/liver and kidney function/heart and lung and other physiological function reserves, expected to successfully complete chemoradiotherapy and immunotherapy. Women of childbearing potential must confirm a negative serum pregnancy test and agree to use effective contraception during study drug use and for 150 days after the last dose. Male patients with sexual partners of childbearing potential must agree to use effective contraception during study drug use and for 150 days after the last dose. Subject is willing and able to comply with visits, treatment regimen, laboratory tests, and other requirements of the study as specified in the schedule. Subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe Exclusion Criteria: 1. subjects with pathologically diagnosed adenocarcinoma or sarcoma of the nasopharynx. 2. subject has other malignancy within 3 years prior to first dose except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are excluded. 3. Participated in treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose. 4. Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator. 5. active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease. 6. History of immunodeficiency; positive HIV antibody test; current chronic use of systemic corticosteroids or other immunosuppressive agents; local, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed. 7. Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection. 8. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 9. history of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis. 10. serious infections within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or serious pneumonia; active infections (excluding antiviral therapy for hepatitis B or C) that have received systemic anti-infective therapy within 2 weeks prior to the first dose. 11. Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA more than 1000 copies/ml [200 IU/ml] or above the lower limit of detection) and anti-hepatitis B virus treatment during study treatment are required for subjects with hepatitis B; subjects with active hepatitis C (HCV antibody positive and HCV-RNA level above the lower limit of detection). 12. any of the following cardiovascular and cerebrovascular diseases: a) myocardial infarction, unstable angina pectoris, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (Grade 2 and above according to the New York Heart Association functional classification), or any arterial thromboembolic event within 6 months before the first dose; b) history of venous thromboembolic events (NCI CTCAE 5.0 version 3 and above), pulmonary embolism, or other serious thromboembolism within 3 months before the first dose; c) presence of serious arrhythmia requiring long-term drug intervention; patients with asymptomatic atrial fibrillation with stable ventricular rate are allowed; d) presence of aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis and other major vascular diseases that may be life-threatening or require surgery within 6 months; e) previous history of myocarditis or cardiomyopathy. 13. Known hypersensitivity to any component of any study drug; known history of serious hypersensitivity to other monoclonal antibodies. 14. known history of mental illness, drug abuse, alcoholism, or drug abuse; 15. pregnant or lactating women. 16. Any previous or current illness, treatment, or laboratory abnormality that may confound the results of the study, affect the subject 's full participation in the study, or that participation may not be in the subject' s best interest.

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

SBRT: Metastases were treated with SBRT, GTV 45Gy/3F/3d, each course of radiotherapy only treated metastases within 1 organ. Chemotherapy(GP or TP) was combined with tislelizumab for 4-6 cycles and tislelizumab was maintained until 2 years or disease progression or intolerable toxicity or death. Maintain: (1) For newly diagnosed metastatic patients, nasopharyngeal and metastatic lymph node irradiation was started 4 weeks after systemic therapy, using IMRT technique, only radiating the GTV of the nasopharyngeal and cervical region, DT 66 Gy/30 F/6 weeks was recommended. Tislelizumab was continued during radiotherapy and tislelizumab was used during maintenance.

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

ORR
target lesion objective response rate after SBRT and 4-6 cycle chemo +immunotherapy

Full Information

First Posted
November 8, 2022
Last Updated
December 5, 2022
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05652192
Brief Title
SBRT Combined With Chemotherapy and Tislelizumab in Metastatic NPC
Official Title
Stereotactic Body Radiotherapy (SBRT) Combined With Chemotherapy and Tislelizumab in Metastatic Nasopharyngeal Carcinoma: A Single-arm, Phase Ⅱ Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Radiotherapy and immunotherapy have achieved good survival benefit in advanced nasopharyngeal carcinoma. A number of clinical studies of immunotherapy combined with radiotherapy for nasopharyngeal carcinoma are also ongoing. This study preliminarily explored the efficacy and safety of SBRT combined with tislelizumab and chemotherapy in metastatic nasopharyngeal carcinoma. Hypofractionated radiotherapy combine with systemic chemotherapy and immunotherapy in advanced nasopharyngeal carcinoma. Not only it can achieve rapid response of distant metastases, but also to achieve long-term survival benefit for patients, which provides the reference for subsequent studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
SBRT for metastatic diseases combined with systemic therapy with GP chemotherapy plus PD-1 antibody
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
SBRT: Metastases were treated with SBRT, GTV 45Gy/3F/3d, each course of radiotherapy only treated metastases within 1 organ. Chemotherapy(GP or TP) was combined with tislelizumab for 4-6 cycles and tislelizumab was maintained until 2 years or disease progression or intolerable toxicity or death. Maintain: (1) For newly diagnosed metastatic patients, nasopharyngeal and metastatic lymph node irradiation was started 4 weeks after systemic therapy, using IMRT technique, only radiating the GTV of the nasopharyngeal and cervical region, DT 66 Gy/30 F/6 weeks was recommended. Tislelizumab was continued during radiotherapy and tislelizumab was used during maintenance.
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
SBRT was added to systematic treatment (chemo+ PD-1 antibody)
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
ORR
Description
target lesion objective response rate after SBRT and 4-6 cycle chemo +immunotherapy
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed a written informed consent form (ICF) voluntarily. Male or female, aged from 18 to 75 years. Pathologically confirmed newly diagnosed or treated metastatic patients are not suitable for radiotherapy. Have not received treatment for metastatic nasopharyngeal carcinoma. At least one metastatic lesion can be treated with SBRT. ECOG score 0-1. Expected survival expectancy of no less than 6 months. Adequate bone marrow/liver and kidney function/heart and lung and other physiological function reserves, expected to successfully complete chemoradiotherapy and immunotherapy. Women of childbearing potential must confirm a negative serum pregnancy test and agree to use effective contraception during study drug use and for 150 days after the last dose. Male patients with sexual partners of childbearing potential must agree to use effective contraception during study drug use and for 150 days after the last dose. Subject is willing and able to comply with visits, treatment regimen, laboratory tests, and other requirements of the study as specified in the schedule. Subjects are willing and able to comply with visits, treatment regimens, laboratory tests, and other requirements of the study as spe Exclusion Criteria: 1. subjects with pathologically diagnosed adenocarcinoma or sarcoma of the nasopharynx. 2. subject has other malignancy within 3 years prior to first dose except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are excluded. 3. Participated in treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose. 4. Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator. 5. active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease. 6. History of immunodeficiency; positive HIV antibody test; current chronic use of systemic corticosteroids or other immunosuppressive agents; local, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed. 7. Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection. 8. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 9. history of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis. 10. serious infections within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or serious pneumonia; active infections (excluding antiviral therapy for hepatitis B or C) that have received systemic anti-infective therapy within 2 weeks prior to the first dose. 11. Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA more than 1000 copies/ml [200 IU/ml] or above the lower limit of detection) and anti-hepatitis B virus treatment during study treatment are required for subjects with hepatitis B; subjects with active hepatitis C (HCV antibody positive and HCV-RNA level above the lower limit of detection). 12. any of the following cardiovascular and cerebrovascular diseases: a) myocardial infarction, unstable angina pectoris, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (Grade 2 and above according to the New York Heart Association functional classification), or any arterial thromboembolic event within 6 months before the first dose; b) history of venous thromboembolic events (NCI CTCAE 5.0 version 3 and above), pulmonary embolism, or other serious thromboembolism within 3 months before the first dose; c) presence of serious arrhythmia requiring long-term drug intervention; patients with asymptomatic atrial fibrillation with stable ventricular rate are allowed; d) presence of aortic aneurysm, aortic dissecting aneurysm, internal carotid artery stenosis and other major vascular diseases that may be life-threatening or require surgery within 6 months; e) previous history of myocarditis or cardiomyopathy. 13. Known hypersensitivity to any component of any study drug; known history of serious hypersensitivity to other monoclonal antibodies. 14. known history of mental illness, drug abuse, alcoholism, or drug abuse; 15. pregnant or lactating women. 16. Any previous or current illness, treatment, or laboratory abnormality that may confound the results of the study, affect the subject 's full participation in the study, or that participation may not be in the subject' s best interest.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Jiang, MD
Phone
0086-571-88128202
Email
jiangfeng@zjcc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
feng Jiang, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Jiang, MD
Phone
0086-571-88128202
Email
jiangfeng@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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SBRT Combined With Chemotherapy and Tislelizumab in Metastatic NPC

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