Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Nanfang Hospital, Southern Medical University
• Treatments: Penicillamine

Criteria

Inclusion Criteria:

1. Sign informed consent

2. The age is 18-75 years

3. Previously received standard radical radiotherapy or chemoradiotherapy

4. Head and neck tumors with in situ or cervical lymph node recurrence confirmed by pathological biopsy and imaging examination

5. ECOG PS：0/1

6. Laboratory examination confirmed good organ function, which should be carried out within 10 days before the first treatment.

Exclusion Criteria:

1. After evaluation, it does not meet the indications of re-radiotherapy

2. Unable to take oral medication

3. Pregnancy or lactation

4. Known allergy to penicillamine

5. Patients who are judged by the researcher as unsuitable to participate in this trial.