Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-12-20
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Proton and Heavy Ion Center
• Treatments: Apatinib

Criteria

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