NCT06103617

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Nov 2023

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

October 15, 2023

Last Update Submit

November 16, 2023

Conditions

Head and Neck CancerRecurrent Cancer

Keywords

radiotherapyradiosensitizerpenicillaminecopper

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Overall survival (OS)

    2 years

  • local-relapse free survival (LRFS)

    2 years

  • Incidence of Treatment-Emergent Adverse Events

    During treatment and 12 weeks after penicillamine treatment

Other Outcomes (1)

  • the biomarkers correlated with ORR, LRFS and OS

    2 years

Study Arms (1)

Penicillamine group

EXPERIMENTAL

Participants in this group are treated with Penicillamine (250mg each time, 4 times per day) during reradiation.

Drug: Penicillamine

Interventions

PenicillamineDRUG

Participants in this group are treated with Penicillamine (250mg each time, 4 times per day) during reradiation.

Penicillamine group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Southern medical university

Guangzhou, Guangdong, 510515, China

RECRUITING

Nanfang Hospital, Sourthern Medical University

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsRecurrence

Interventions

Penicillamine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jian Guan, M.D

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Guan, M.D

CONTACT

+86-136321022451643930@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2023

First Posted

October 27, 2023

Study Start

November 15, 2023

Primary Completion

October 30, 2024

Study Completion

June 1, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

CN(2)