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

• Status: Recruiting
• Trial end date: 2025-07-31
• Target enrollment: 0
• Participant gender: Male

Summary

Primary Objective:To evaluate the efficacy and safety of TIP (paclitaxel + ifosfamide + cisplatin) combined with nimotuzumab & triprilimab as neoadjuvant treatment in locally advanced penile cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Albumin-Bound Paclitaxel; Ifosfamide; Nimotuzumab; Paclitaxel

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

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.