RecruitingPhase 2NCT06415318

TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer

A Single-center, Single-arm Clinical Study of TIP(Paclitaxel + Ifosfamide + Cisplatin) Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer


Sponsor

Sun Yat-sen University

Enrollment

25 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Primary Objective: To evaluate the efficacy and safety of TIP (paclitaxel + ifosfamide + cisplatin) combined with Toripalimab as a neoadjuvant treatment in locally advanced penile cancer


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of chemotherapy drugs (called the TIP regimen) plus an immunotherapy drug (triplizumab) given before surgery for locally advanced penile cancer. The goal is to shrink the tumor before surgery, which may allow for better surgical outcomes. **You may be eligible if...** - You have been diagnosed with locally advanced penile cancer confirmed by biopsy - Your cancer is at an advanced local stage (T4 or N3, or both) - You have not had chemotherapy before, or your cancer relapsed more than 12 months after your last treatment - You have at least one measurable tumor visible on scans - Your general health is good (ECOG score 0–2) - Your blood counts and organ function are within acceptable ranges - Your expected survival is at least 12 months **You may NOT be eligible if...** - You have significant nerve damage affecting your daily function - You received an experimental drug in the 4 weeks before enrolling - You have another active cancer (with some exceptions for fully treated, low-risk cancers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel + Ifosfamide + Cisplatin & Toripalimab

Paclitaxel + Ifosfamide + Cisplatin \& Toripalimab


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06415318


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