Combination of TIP Regimen and Toripalimab for 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
This study is testing a new combination of chemotherapy and an immune treatment for patients with advanced penile cancer to see if it helps them do better before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, Toripalimab, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06415318 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a combination treatment using the TIP regimen (paclitaxel, ifosfamide, and cisplatin) along with Toripalimab, an immune checkpoint inhibitor, as neoadjuvant therapy for patients with locally advanced penile cancer. The study focuses on patients with squamous cell carcinoma who have not received prior chemotherapy and have measurable lesions. By targeting both the tumor directly with chemotherapy and enhancing the immune response with immunotherapy, the trial aims to improve patient outcomes, particularly for those with lymph node metastasis.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with locally advanced penile squamous cell carcinoma who meet specific health criteria and have not undergone prior chemotherapy.
Not a fit: Patients with peripheral neuropathy grade 2 or higher or those with serious systemic organ diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with locally advanced penile cancer.
How similar studies have performed: Previous studies have shown promising results with similar approaches using PD-1 inhibitors in other types of squamous cell carcinomas, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hui Han
- Email: hanhui@sysucc.org.cn
- Phone: 13002018798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.