🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06415318
Recruiting Phase 2

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

NCT06415318 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2024-05-31
Last updated
2025-04-22

Condition(s) studied

Penile Cancer

Investigational drug(s) / intervention(s)

Paclitaxel + Ifosfamide + Cisplatin & Toripalimab

Paclitaxel + Ifosfamide + Cisplatin & Toripalimab: Paclitaxel + Ifosfamide + Cisplatin \& Toripalimab

Study 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
MALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Squamous cell carcinoma confirmed by histology or cytology; 2. Clinical Stage is Locally advanced penile cancer (T4, any N stage; or any T stage, N3); 3. No prior chemotherapy for newly diagnosed or relapsed patients or the time from the last chemotherapy to relapse should be longer than 12 months; 4. There is at least one measurable lesion according to the solid tumor efficacy evaluation standard RECIST1.1; 5. the Eastern Cooperative Oncology Group (ECOG) scored 0-2; 6. Blood marrow function: Hemoglobin(Hb) \>/= 80g/L; White blood cell count \>/= 3.0x10\^9/L; Neutrophil count \>/= 1.5x10\^9/L; Platelet count \>/ = 100x10\^9/L; 7. Liver function: AST, ALT, ALP \</= 2.5 ULN; Total bilirubin \</= 1.5 ULN; 8. Estimated survival \>/= 12 months; 9. No prior serious disease history of a systemic organ; 10. The participant understands this study procedure and signs the informed consent. Exclusion Criteria: 1. Peripheral neuropathy degree \>/=2 (affecting patient's function); 2. Previously received any other experimental drug treatment within 4 weeks before enrollment; 3. Patients with other cancer at present, or have other malignant tumor histories within the past 5 years. Except for (1) Cured skin non-malignant melanoma; (2) Curable tumor, including low-risk prostate cancer (T1a, Gleason score\<6, PSA\<0.5ng/ml), superficial bladder cancer and so on; (3) Other solid tumors have received radical treatment, and no recurrence or metastasis has been found at least 5 years; 4. Other serious or poorly controlled concomitant diseases, including but not limited to (1) Severe or acute attack disease history of cardiovascular, liver, respiratory, kidney, blood, endocrine or neuropsychiatric system within 6 months; (2) Active infection history and needed antibiotic treatment within 2 weeks before enrollment; (3) Congestive heart failure (grade III-IV); (4) Unstable angina pectoris or myocardial infarction history within 6 months

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

More Sun Yat-sen University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06415318 on ClinicalTrials.gov ↗ ← All trials in China