A Single Center and Single Arm Study of TIP (Paclitaxel + Ifosfamide + Cisplatin) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer

Sun Yat-sen University1 个研究点分布在 1 个国家目标入组 29 人开始时间: 2020年8月12日最近更新: 2022年6月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 29
试验地点: 1
主要终点: Percentage of Participants With Pathologically Complete Response

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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) may improve their prognosis. TIP (Paclitaxel + Ifosfamide + Cisplatin) regimen is the first line neoadjuvant treatment recommended by NCCN guidelines. Epidermal growth factor receptor (EGFR) plays a vital role in the development of penile cancer. It's also an important therapeutic target for penile cancer. PD-1 is an immune checkpoint molecule on the surface of T cells. In recent years, immune-checkpoint inhibitors targeting PD-1 have shown good efficacy in a variety of tumors. Some phase II / III clinical trials have shown that PD-1 inhibitors can improve the prognosis of patients with lung squamous cell carcinoma, head and neck squamous cell carcinoma and cervical cancer. Previous studies have found that PD-L1 is highly expressed in 40% - 60% of penile cancer, suggesting that penile cancer patients may benefit from immunotherapy.

The management of penile cancer with lymph node metastasis is difficult, especially for N2-3 stage. This phase II study aim to explore an effective combination therapy for locally advanced penile cancer. 29 patients need to be enrolled.TIP & nimotuzumab & triprilimab will be administered per 21-day until surgery, evidence of disease progression or onset of unacceptable toxicity.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 否

入选标准

•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;
•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 systemic organ;
•The participant unterstand this study procedure and sign the informed consent.

排除标准

•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 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;
•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.