Overview
Our preclinical study confirmed that copper accumulation can lead to radioresistance in vitro and in vivo, and reducing the concentration of copper with copper chelator help to overcome radioresistance. Therefore, the investigators plan to carry out a prospective interventional phase II clinical trial to explore the safety and efficacy of penicillamine (a common copper chelator) as a radiosensitizer in the treatment of recurrent head and neck cancer.
Description
Head and neck cancer is the sixth most common cancer worldwide. Radiotherapy is an important measure to control tumor recurrence. Although radiotherapy has been widely used in patients with head and neck cancer, the 2-year local recurrence rate of patients with locally advanced disease is still as high as 50%-60%. This is associated with a lower radiosensitivity in head and neck cancer. High doses of reirradiation (>60 Gy) are associated with severe late complications and treatment-related mortality. Therefore, finding an appropriate sensitizer to improve the radiosensitivity is the key to improve the survival of recurrent patients. Our preclinical study confirmed that copper accumulation can lead to radioresistance in vitro and in vivo, and the results were published in J Hepatol (IF=25.7). Penicillamine is a commonly used copper chelator in clinical practice and can reduce the concentration of copper in the body. Based on this, the investigators plan to carry out a prospective interventional phase II clinical trial to explore the safety and efficacy of penicillamine as a radiosensitizer in the treatment of recurrent head and neck cancer.
Eligibility
Inclusion Criteria:
- Sign informed consent
- The age is 18-75 years
- Previously received standard radical radiotherapy or chemoradiotherapy
- Head and neck tumors with in situ or cervical lymph node recurrence confirmed by pathological biopsy and imaging examination
- ECOG PS：0/1
- Laboratory examination confirmed good organ function, which should be carried out within 10 days before the first treatment.
Exclusion Criteria:
- After evaluation, it does not meet the indications of re-radiotherapy
- Unable to take oral medication
- Pregnancy or lactation
- Known allergy to penicillamine
- Patients who are judged by the researcher as unsuitable to participate in this trial.