A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorFujian Medical University Union Hospital
About this trial
The goal of this clinical trial is to learn if Disitamab Vedotin combined with Toripalimab works to treat advanced HER2-positive extramammary Paget disease of the scrotum. It will also learn about the safety of this combination. The main questions it aims to answer are: Does this combination reduce tumor volume and delay disease progression? What medical problems do participants have when receving this combination? Participants will: Intravenous using this combination every 3 weeks until disease progression or intolerable adverse reactions occur. Visit the clinic once every 3 weeks for checkups and tests.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Disitamab Vedotin combined with Toripalimab
DrugDisitamab Vedotin at a dosage of 2mg/kg and 3mg/kg of Toripalimab administered intravenously every 3 weeks (ivgtt q3w) is continued until disease progression, with the allowance for treatment discontinuation due to disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antineoplastic therapy, or other reasons specified in the protocol, with the earliest occurring event taking precedence. Alternatively, the study investigator may determine the need to discontinue treatment.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate
ORR includes two categories: Complete Response (CR): All target lesions in the patient have completely disappeared, and no new lesions have appeared for a certain time. Partial Response (PR): The tumor in the patient has reduced in size by at least 30%, and this reduction has been maintained for a certain period.
Time frame
every 6 weeks,up to 24 weeksSecondary outcomes
1
Progression free survival
Progression-Free Survival (PFS) is a clinical endpoint used primarily in oncology to measure the effectiveness of a treatment in delaying the progression of a disease. It is defined as the length of time during which a patient's disease does not get worse after starting a treatment. PFS takes into account the time from the start of treatment until the first occurrence of disease progression, or the patient's death if it occurs before progression.
Time frame
through study completion, an average of 2 year2
Adverse events
adverse events
Time frame
through study completion, an average of 2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fujian Medical University Union Hospital
Lead sponsor
Zhejiang Tumor Hospital
Collaborator
Fujian Provincial Hospital
Collaborator
Zhangzhou Affiliated Hospital of Fujian Medical University
Collaborator
Quanzhou First Hospital
Collaborator
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Source ClinicalTrials.gov