Combining carbon-ion radiotherapy with camrelizumab for recurrent nasopharyngeal cancer
A Phase 2 Randomized Clinical Trial to Examine the Efficacy of Carbon-Ion Radiotherapy Plus Camrelizumab As Salvage Treatment for Locally Recurrent Nasopharyngeal Carcinoma
This study is testing whether adding a new immunotherapy drug called camrelizumab to carbon-ion radiotherapy can help people with recurrent nasopharyngeal cancer live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Proton and Heavy Ion Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, camrezlizumab, camrelizumab |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04143984 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of camrelizumab in conjunction with carbon-ion radiotherapy (CIRT) for patients suffering from locally recurrent nasopharyngeal carcinoma (LR-NPC). A total of 146 participants will be randomly assigned to receive either CIRT alone or CIRT plus camrelizumab. The primary focus is on progression-free survival, while secondary outcomes include overall survival and various forms of progression-free survival. The trial seeks to clarify the potential benefits of combining immunotherapy with advanced radiotherapy techniques in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who have experienced recurrence of nasopharyngeal carcinoma more than six months after initial treatment and have measurable lesions.
Not a fit: Patients with distant metastasis or those who have previously received radioactive particle implantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve progression-free survival rates for patients with locally recurrent nasopharyngeal carcinoma.
How similar studies have performed: While carbon-ion radiotherapy has shown promise in treating nasopharyngeal carcinoma, the combination with camrelizumab is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai
- Shanghai Proton and Heavy Ion Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jiade J Lu, MD — Shanghai Proton and Heavy Ion Center
- Study coordinator: Jiyi Hu, MD, PhD
- Email: jiyi.hu@sphic.org.cn
- Phone: +8602138296666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.