TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer
Recruiting now · Phase 2
Conditions studied: Penile Cancer
In brief
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
Key facts
- Study ID
- NCT06415318
- Run by
- Sun Yat-sen University
- People needed
- 25
- Starts
- 2024-05-31
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2025-04-22
Who can join
Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Squamous cell carcinoma confirmed by histology or cytology;
- Clinical Stage is Locally advanced penile cancer (T4, any N stage; or any T stage, N3);
- No prior chemotherapy for newly diagnosed or relapsed patients or the time from the last chemotherapy to relapse should be longer than 12 months;
- There is at least one measurable lesion according to the solid tumor efficacy evaluation standard RECIST1.1;
- the Eastern Cooperative Oncology Group (ECOG) scored 0-2;
- 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;
- Liver function: AST, ALT, ALP </= 2.5 ULN; Total bilirubin </= 1.5 ULN;
- Estimated survival >/= 12 months;
- No prior serious disease history of a systemic organ;
- The participant understands this study procedure and signs the informed consent.
You may not qualify if…
- Peripheral neuropathy degree >/=2 (affecting patient's function);
- Previously received any other experimental drug treatment within 4 weeks before enrollment;
- 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;
- 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
Where it is running
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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