Combining RT With Toripalimab and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Apr 30, 2024
  • participants needed
    34
  • sponsor
    Chinese Academy of Medical Sciences
Send
Updated on 7 June 2022
See if I qualify

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.

Details
Condition Metastatic Nasopharyngeal Cancer
Treatment Radiotherapy
Clinical Study IdentifierNCT05385926
SponsorChinese Academy of Medical Sciences
Last Modified on7 June 2022

Eligibility

 Yes No Not Sure

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 Gemcitabine plus cisplatin combined with Toripalimab
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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note