Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Brief Title:
TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Single-center Single-arm Clinical Study of TIPPaclitaxel Ifosfamide Cisplatin Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Penile cancer is a rare malignant tumor which often occurs in the inner plate of the prepuce and glans Squamous cell carcinoma is the most common pathological type Lymph node metastasis is a crucial factor that leads to poor prognosis of penile cancer The 5-year OS of penile cancer patients without lymph node metastasis is 90 Still it goes down sharply in patients with inguinal lymph node metastasis and pelvic lymph node metastasis which is 50 and 0 respectively Using neoadjuvant chemotherapy to treat patients with locally advanced penile cancer T4 any N stage or any T stage N3 may improve their prognosis TIP Paclitaxel Ifosfamide Cisplatin regimen is the first-line neoadjuvant treatment recommended by NCCN guidelines PD-1 is an immune checkpoint molecule on the surface of T cells In recent years immune checkpoint inhibitors targeting PD-1 have shown good efficacy in a variety of tumors Some phase II III clinical trials have shown that PD-1 inhibitors can improve the prognosis of patients with lung squamous cell carcinoma head and neck squamous cell carcinoma and cervical cancer Previous studies have found that PD-L1 is highly expressed in 40 - 60 of penile cancer suggesting that penile cancer patients may benefit from immunotherapy The management of penile cancer with lymph node metastasis is difficult especially for the N2-3 stage This phase II study aims to explore an effective combination therapy for locally advanced penile cancer 25 patients need to be enrolledTIP toripalimab will be administered every 21 days until surgery evidence of disease progression or onset of unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None