Clinical trial · Interventional
Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer
Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer: a Single-center, Single-arm, Phase II Clinical Trial
- 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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Recurrent Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Penicillamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Penicillamine group
- description
- Participants in this group are treated with Penicillamine (250mg each time, 4 times per day) during reradiation.
- interventionNames
- Drug: Penicillamine
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 1 month
- description
- The objective response rate (ORR) is the proportion of patients who achieve a prespecified reduction in tumor volume that is maintained for a minimum duration. The objective response rate was defined as the sum of complete response plus partial response (CR+PR). According to RECIST1.1 criteria, CR was defined as the disappearance of target lesions and the reduction of the short diameter of pathological lymph nodes to less than 10mm. PR: the sum of the measured diameters of the target lesions reduced by 30% compared with the baseline; PD: the sum of the major diameters of all target lesions increased by at least 20%, and the absolute value of the sum of the major diameters increased by more than 5mm, or new lesions appeared. SD: Changes between PR and PD.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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