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

Launched by SUN YAT-SEN UNIVERSITY · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for men with locally advanced penile cancer, which is a type of cancer that starts in the cells of the penis. The trial is testing a combination of three chemotherapy drugs—paclitaxel, ifosfamide, and cisplatin (collectively known as TIP)—along with a medication called Toripalimab. This combination is being given before surgery to see if it can effectively shrink the cancer and improve patient outcomes.

To participate in this trial, you need to be a male aged between 18 and 75 years and have been diagnosed with a specific type of penile cancer called squamous cell carcinoma. You should not have received chemotherapy for your cancer before, and you must have measurable cancer lesions. Participants can expect to receive close monitoring throughout the trial to check how well the treatment is working and to ensure their safety. It's important to discuss with your doctor whether this trial is the right option for you, especially if you have any other serious health conditions.

Gender

MALE

Eligibility criteria

• 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