Actively Recruiting
TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer
Led by Sun Yat-sen University · Updated on 2025-04-22
25
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 to 75 years
- Histologically or cytologically confirmed squamous cell carcinoma of penile cancer
- Locally advanced penile cancer stage T4 any N, or any T stage N3
- No prior chemotherapy for newly diagnosed or relapse with last chemotherapy more than 12 months ago
- At least one measurable lesion according to RECIST1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Blood marrow function with Hb 80g/L, WBC count 3.0x10^9/L, neutrophil count 1.5x10^9/L, platelet count 100x10^9/L
- Liver function with AST, ALT, ALP 2.5 times upper limit of normal (ULN); total bilirubin 1.5 ULN
- Estimated survival time of at least 12 months
- No history of serious systemic organ disease
- Participant understands study procedures and signs informed consent
You will not qualify if you...
- Peripheral neuropathy grade 2 or higher affecting function
- Received other experimental drug treatments within 4 weeks before enrollment
- Other active cancers or history of other malignant tumors within past 5 years, except cured non-malignant melanoma, low-risk prostate cancer, superficial bladder cancer, or fully treated solid tumors with no recurrence for at least 5 years
- Serious or uncontrolled diseases including recent severe cardiovascular, liver, respiratory, kidney, blood, endocrine, or neuropsychiatric conditions within 6 months
- Active infection requiring antibiotics within 2 weeks before enrollment
- Congestive heart failure grade III-IV
- Unstable angina or heart attack within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
Hui Han
CONTACT
T
Ting Xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here