TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer
ConditionPenile Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-75
SponsorSun Yat-sen University
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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
Trial design
Treatments tested in this trial
- Paclitaxel + Ifosfamide + Cisplatin & Toripalimab
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov