Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Registration Number
- NCT04143984
- Lead Sponsor
- Shanghai Proton and Heavy Ion Center
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 146
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm-C Induction chemotherapy 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). Arm-C Carbon-ion radiotherapy 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). Arm-CC Induction chemotherapy 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. Arm-CC Carbon-ion radiotherapy 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. Arm-CC Camrelizumab 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.
- Primary Outcome Measures
Name Time Method Progression-free survival 2-year Duration from randomization to documented disease recurrence or death from any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Local progression-free survival 2-year Duration from randomization to documented local recurrence or death from any cause, whichever occurs first.
Overall survival 2-year Duration from randomization to death from any cause.
Regional progression-free survival 2-year Duration from randomization to documented regional recurrence or death from any cause, whichever occurs first.
Number of participants with adverse events 2-year Incidence of adverse events
Distant metastasis-free survival 2-year Duration from randomization to documented distant metastasis or death from any cause, whichever occurs first.
Trial Locations
- Locations (1)
Shanghai Proton and Heavy Ion Center
🇨🇳Shanghai, Shanghai, China