Clinical trial · Interventional
Carbon-Ion Radiotherapy Plus Camrelizumab for Locally Recurrent Nasopharyngeal Carcinoma
A Phase 2 Randomized Clinical Trial to Examine the Efficacy of Carbon-Ion Radiotherapy Plus Camrelizumab As Salvage Treatment for Locally Recurrent Nasopharyngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab | ALIAS |
| Carbon-ion radiotherapy | Radiation | — | UNRESOLVED |
| Induction chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm-C
- description
- 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).
- interventionNames
- Drug: Induction chemotherapy
- Radiation: Carbon-ion radiotherapy
- type
- EXPERIMENTAL
- label
- Arm-CC
- description
- 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.
- interventionNames
- Drug: Induction chemotherapy
- Radiation: Carbon-ion radiotherapy
- Drug: Camrelizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHu J, Huang Q, Hu W, Gao J, Yang J, Zhang H, Lu JJ, Kong L. A protocol for a randomized trial evaluating the role of carbon-ion radiation therapy plus camrelizumab for patients with locoregionally recurrent nasopharyngeal carcinoma. Cancer Med. 2024 Feb;13(3):e6742. doi: 10.1002/cam4.6742. Epub 2024 Jan 11. PMID 38205914