Trials Sponsors Conditions Drugs Pricing

Conditions

Extramammary Paget Disease Scrotum Disease

Outcome Measures

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.
every 6 weeks,up to 24 weeks

Secondary Outcomes (2)

Progression free survival
through study completion, an average of 2 year
advance events
through study completion, an average of 2 year

Study Arms (1)

Drug: Disitamab Vedotin combined with Bicalutamide

EXPERIMENTAL

Drug: Disitamab Vedotin combined with Bicalutamide

Interventions

Disitamab Vedotin combined with BicalutamideDrug

Single Group Assignment

Drug: Disitamab Vedotin combined with Bicalutamide

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntarily sign the informed consent form and comply with the requirements of the protocol.
Age ≥ 18 years old.

Sponsors & Collaborators

Fujian Province Tumor Hospital
Othercollaborator
Qinghai Province Fifth People's Hospital
Othercollaborator
Fudan University

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200230, China

RECRUITING

Hengchuan Su, Chief physicianCONTACT+8621-64175590 suhengchuan@163.com

MeSH Terms

Conditions

Paget Disease, Extramammary

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and Medullary

Central Study Contacts

Hengchuan Su

CONTACT

021-6417 5590 suhengchuan@163.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of urology

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

August 1, 2025

Actual (reported)

Primary Completion

December 30, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
Have had active autoimmune diseases within 2 years prior to the start of the study treatment that required systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants), except for replacement therapies (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency); currently receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy.
The dose is \>10mg/day of prednisone or other equivalent hormones, and it is within 2 weeks of the first administration and still in use;
Have a history of active tuberculosis;
Have uncontrollable, recurrent drainage of ascites, pericardial effusion, or pleural effusion;
Have undergone major organ transplantation;
Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the study treatment; or have chronic non-healing wounds or fractures;
Have a history of live attenuated vaccine administration within 14 days prior to the start of the study treatment or plan to receive live attenuated vaccine vaccination during the study period;
Have had a severe hypersensitivity reaction after the use of monoclonal antibodies; known allergy to the active ingredients or excipients of this study drug;
Within 4 weeks prior to the start of the study, are participating in or have participated in other clinical studies;
Have a history of severe allergies;
Have a risk of bleeding, or coagulation dysfunction, or are currently receiving -thrombolytic therapy;
Have a history of substance abuse and are unable to quit or have mental disorders;
According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study, or there are other reasons deemed unsuitable for enrollment by the investigator.

A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Drug: Disitamab Vedotin combined with Bicalutamide

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Drug: Disitamab Vedotin combined with Bicalutamide

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations