- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04143984
Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma
April 24, 2022 updated by: Jiade J. Lu, Shanghai Proton and Heavy Ion Center
A Phase 2 Randomized Clinical Trial to Examine the Efficacy of Carbon-Ion Radiotherapy Plus Camrelizumab As Salvage Treatment for Locally Recurrent Nasopharyngeal Carcinoma
The purpose of this trial is to examine the role of camrezlizumab in addition to carbon-ion radiotherapy (CIRT) for patients with locally recurrent nasopharyngeal carcinoma.
According to the plan, a total of 146 patients will be recruited and randomized into: 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Treatment for locally recurrent nasopharyngeal carcinoma (LR-NPC) is challenging.
Carbon-ion radiotherapy appeared to be an effective treatment for this group of patients, and has substantially improved the 2-year overall survival (OS) to approximately 85%, compared to photon-based intensity-modulated radiotherapy.
However, a group of the patients may still develop disease progression after CIRT, and the 2-year progression-free survival (PFS) was approximately 45%-50%.
Camrelizumab, a programmed cell death 1 (PD-1) inhibitor, has been demonstrated that it is effective in the recurrent/metastatic nasopharyngeal carcinoma; however, the role of camrelizumab in concurrence with radiotherapy, especially CIRT, for LR-NPC is not clear.
The purpose of this phase 2 clinical trial is to compare the efficacy of CIRT plus camrelizumab and CIRT alone in the treatment of LR-NPC.
Eligible participants will be randomized (1:1) to 1) CIRT alone group (control group); 2) CIRT plus camrelizumab group (experimental group).
The primary endpoint is progression-free survival.
Secondary endpoints include overall survival (OS), local progression-free survival (LPFS), regional progression-free survival (RPFS), and distant metastasis-free survival (DMFS) and toxicities.
All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Study Type
Interventional
Enrollment (Anticipated)
146
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiyi Hu, MD, PhD
- Phone Number: 53513 +8602138296666
- Email: jiyi.hu@sphic.org.cn
Study Contact Backup
- Name: Lin Kong, MD
- Phone Number: 53516 +8602138296666
- Email: konglin@sphic.org.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201315
- Recruiting
- Shanghai Proton and Heavy Ion Center
-
Contact:
- Jiyi Hu, MD, PhD
- Phone Number: 53513 +8602138296666
- Email: jiyi.hu@sphic.org.cn
-
Contact:
- Lin Kong, MD
- Phone Number: 53516 +8602138296666
- Email: konglin@sphic.org.cn
-
Sub-Investigator:
- Lin Kong, MD
-
Sub-Investigator:
- Jiyi Hu, MD, PhD
-
Sub-Investigator:
- Weixu Hu, MD
-
Sub-Investigator:
- Jing Yang, MD
-
Sub-Investigator:
- Jing Gao, MD
-
Sub-Investigator:
- Xianxin Qiu, MD
-
Sub-Investigator:
- Qingting Huang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Completed a definitive course of intensity-modulated photon radiation therapy (IMRT) to a total dose of ≥ 66 Gy
- Recurrence at nasopharynx diagnosed more than 6 months after the initial course of IMRT
- Patients with neck lymphadenopathy should receive neck dissection before randomization
- With measurable lesion on contrast MR scan
- Age ≥ 18 and < 70 years of age
- ECOG score: 0-1
- Leucocyte count ≥ 4000/µL, neutrocyte count ≥ 2000/µL, platelet count ≥ 100000/µL, hemoglobin ≥ 90g/L
- Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN), alkaline phosphatase < 2.5×ULN, bilirubin ≤ ULN, serum creatinine ≤ ULN, creatinine clearance ≥ 60ml/min
- Willing to accept adequate contraception
- Ability to understand the nature of the clinical trial and sign the written informed consent
Exclusion Criteria:
- Presence of distant metastasis
- Previously received radioactive particle implantation
- Prior malignancy within 5 years before randomization, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer
- Patients who received local (such as surgery and cryotherapy) or systemic treatment, except for induction chemotherapy after diagnosis of recurrence
- With uncontrolled active infection
- With pneumonia
- With autoimmune disease
- With a known history of testing positive for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- Hepatitis B virus (HBV) DNA ≥ 500IU/mL for patients with positive HBV surface antigen, positive hepatitis C virus RNA for patients with positive HCV antigen
- Previously treated by immune checkpoint inhibitors
- Medical conditions requiring treatment of antibiotics and/or corticosteroid
- Treated with ≥ 5 days antibiotics one month before start of immunotherapy
- With known allergy to any of the study drugs
- Pregnant or lactating women
- Any severe intercurrent disease that may interfere with the current study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Arm-C
Patients will receive induction chemotherapy followed by carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE).
|
Induction chemotherapy with the regimen of gemcitabine plus nedaplatin.
Accelerated carbon-ion beam with pencil beam scanning technique.
|
EXPERIMENTAL: Arm-CC
Patients will receive induction chemotherapy followed by carbon-ion radiotherapy and camrelizumab.
In details, patients will receive carbon-ion radiotherapy with a dose of 63 GyE in 21 fractions (the fraction size is 3 GyE); in addition, patients will also receive camrelizumab of 200 mg (IV.), every 2 weeks, started with carbon-ion radiotherapy for a maximal period of 1 year.
|
Induction chemotherapy with the regimen of gemcitabine plus nedaplatin.
Accelerated carbon-ion beam with pencil beam scanning technique.
An anti-PD-1 antibody.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: 2-year
|
Duration from randomization to documented disease recurrence or death from any cause, whichever occurs first.
|
2-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 2-year
|
Duration from randomization to death from any cause.
|
2-year
|
Local progression-free survival
Time Frame: 2-year
|
Duration from randomization to documented local recurrence or death from any cause, whichever occurs first.
|
2-year
|
Regional progression-free survival
Time Frame: 2-year
|
Duration from randomization to documented regional recurrence or death from any cause, whichever occurs first.
|
2-year
|
Distant metastasis-free survival
Time Frame: 2-year
|
Duration from randomization to documented distant metastasis or death from any cause, whichever occurs first.
|
2-year
|
Number of participants with adverse events
Time Frame: 2-year
|
Incidence of adverse events
|
2-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 19, 2021
Primary Completion (ANTICIPATED)
December 20, 2025
Study Completion (ANTICIPATED)
December 20, 2025
Study Registration Dates
First Submitted
October 27, 2019
First Submitted That Met QC Criteria
October 27, 2019
First Posted (ACTUAL)
October 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 29, 2022
Last Update Submitted That Met QC Criteria
April 24, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- SPHIC-TR-HNCNS-2019-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data on participants' clinical features, treatment modalities, survivals and toxicity profile will be shared upon reasonable request.
Detailed study protocol should be emailed along with the request of the data.
We may carefully review the study protocol, and data will only be shared with well-designed studies.
IPD Sharing Time Frame
Within 3 years after publication of the study.
IPD Sharing Access Criteria
Data mentioned in the plan description and relevant supporting files will be shared with radiation oncologist who are interested in conducting pooled analysis comparing carbon-ion radiotherapy with other treatment modalities (such as other radiation technique and systemic therapy) for patients with recurrent nasopharyngeal carcinoma.
The IPD will only be shared after the study protocol is reviewed and approved by the principle investigator.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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