TIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer

Launched by SUN YAT-SEN UNIVERSITY · Jul 16, 2020

Keywords

ClinConnect Summary

Penile cancer is a rare malignant tumor, which often occurs in the inner plate of prepuce and glans. Squamous cell carcinoma is the most common pathological type. Lymph node metastasis is a crucial factor that leads to poor prognosis of penile cancer. The 5-year OS of penile cancer patients without lymph node metastasis is 90%. Still, it goes down sharply in patients with inguinal lymph node metastasis and pelvic lymph node metastasis, which is 50% and 0%, respectively.

Using neoadjuvant chemotherapy to treat patients with locally advanced penile cancer (T4, any N stage, or any T stage, N3...

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;
• • 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 systemic organ;
• • 10. The participant unterstand this study procedure and sign 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 malignent tumor history within 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.