Actively Recruiting
SBRT Combined With Chemotherapy and Tislelizumab in Metastatic NPC
Led by Zhejiang Cancer Hospital · Updated on 2022-12-15
37
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SBRT Combined With Chemotherapy and Tislelizumab in Metastatic NPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed a written informed consent form voluntarily
- Male or female, aged from 18 to 75 years
- Pathologically confirmed newly diagnosed or treated metastatic nasopharyngeal carcinoma patients not suitable for radiotherapy
- No prior treatment for metastatic nasopharyngeal carcinoma
- At least one metastatic lesion can be treated with SBRT
- ECOG performance status 0-1
- Expected survival of at least 6 months
- Adequate bone marrow, liver, kidney, heart, lung and other physiological functions to complete treatment
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and for 150 days after treatment
- Male patients with partners of childbearing potential must agree to use contraception during and for 150 days after treatment
- Willing and able to comply with study visits, treatment regimens, and laboratory tests
You will not qualify if you...
- Pathologically diagnosed adenocarcinoma or sarcoma of the nasopharynx
- Other malignancy within 3 years prior to first dose except cured local skin, bladder, cervical, or breast carcinoma in situ
- Use of investigational drugs or devices within 4 weeks prior to first dose
- Active autoimmune disease requiring systemic treatment within 2 years prior to first dose or likely to recur
- Active or previous inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- History of immunodeficiency, positive HIV antibody test, or current chronic use of systemic corticosteroids or immunosuppressive agents
- Active pulmonary tuberculosis or syphilis infection
- History of allogeneic organ or hematopoietic stem cell transplantation
- History of pneumonitis or interstitial lung disease requiring systemic corticosteroids or current pneumonitis
- Serious infections within 4 weeks prior to first dose or active infections treated within 2 weeks prior to first dose
- Untreated active hepatitis B or active hepatitis C infection
- Certain cardiovascular and cerebrovascular diseases within specified recent time frames
- Known hypersensitivity to study drugs or other monoclonal antibodies
- History of mental illness, drug abuse, alcoholism
- Pregnant or lactating women
- Any condition that may interfere with study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
F
Feng Jiang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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