Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Phase 2 Randomized Clinical Trial to Examine the Efficacy of Carbon-Ion Radiotherapy Plus Camrelizumab As Salvage Treatment for Locally Recurrent Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143984
• Other study ID #: SPHIC-TR-HNCNS-2019-34
• Status: Recruiting
• Phase: Phase 2
• Start date: January 19, 2021
• Est. completion date: December 20, 2025

Study information

• Verified date: April 2022
• Source: Shanghai Proton and Heavy Ion Center
• Contact: Jiyi Hu, MD, PhD
• Phone: +8602138296666
• Email: jiyi.hu[@]sphic.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: December 20, 2025
• Est. primary completion date: December 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Induction chemotherapy
Induction chemotherapy with the regimen of gemcitabine plus nedaplatin.

Radiation:
• Carbon-ion radiotherapy
Accelerated carbon-ion beam with pencil beam scanning technique.

Drug:
• Camrelizumab
An anti-PD-1 antibody.

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Duration from randomization to documented disease recurrence or death from any cause, whichever occurs first.	2-year
Secondary	Overall survival	Duration from randomization to death from any cause.	2-year
Secondary	Local progression-free survival	Duration from randomization to documented local recurrence or death from any cause, whichever occurs first.	2-year
Secondary	Regional progression-free survival	Duration from randomization to documented regional recurrence or death from any cause, whichever occurs first.	2-year
Secondary	Distant metastasis-free survival	Duration from randomization to documented distant metastasis or death from any cause, whichever occurs first.	2-year
Secondary	Number of participants with adverse events	Incidence of adverse events	2-year