Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05652192

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

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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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