RecruitingPhase 2NCT06415318

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

A Single-center, Single-arm Clinical Study of TIP(Paclitaxel + Ifosfamide + Cisplatin) Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer

Sponsor

Sun Yat-sen University

Enrollment

25 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Penile Cancer

Summary

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

Sex: MALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria10

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;
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 a systemic organ;
The participant understands this study procedure and signs the informed consent.

Exclusion Criteria4

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

Interventions

DRUGPaclitaxel + Ifosfamide + Cisplatin & Toripalimab

Paclitaxel + Ifosfamide + Cisplatin \& Toripalimab

Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06415318

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