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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penicillamine group | Experimental | Participants in this group are treated with Penicillamine (250mg each time, 4 times per day) during reradiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penicillamine | Drug | Participants in this group are treated with Penicillamine (250mg each time, 4 times per day) during reradiation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS was defined as the time from the date of inclusion until death from any cause. | 2 years |
| local-relapse free survival (LRFS) | LRFS was defined as the time from the date of inclusion until tumor relapse. |
| Measure | Description | Time Frame |
|---|---|---|
| the biomarkers correlated with ORR, LRFS and OS | The correlations between ORR, OS, LRFS and PD-L1 expression in tissues, tumor mutation burden, tumor-related gene changes, plasma cytokines or other biomarkers were explored. | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Guan, M.D | Contact | +86-1363210224 | 51643930@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Guan, M.D | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern medical university | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010396 | Penicillamine |
| ID | Term |
|---|---|
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
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| 2 years |
| Incidence of Treatment-Emergent Adverse Events | treatment-related adverse events will be assessed by CTCAE v5.0 | During treatment and 12 weeks after penicillamine treatment |
| Nanfang Hospital, Sourthern Medical University | Recruiting | Guangzhou | China |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |