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New treatment option for Penile Cancer
Official title TIP Regimen Combined With Triplizumab Neoadjuvant Therapy for Locally Advanced Penile Cancer
ClinicalTrials.gov ID: NCT06415318
What this study is testing
What is Paclitaxel + Ifosfamide + Cisplatin & Toripalimab?
Paclitaxel + Ifosfamide + Cisplatin & Toripalimab is an investigational medicine, being studied as a potential treatment for penile cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, men only
You may be able to join if
- 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 how well it works evaluation standard RECIST1.1;
- the Eastern Cooperative Oncology Group (ECOG) scored 0-2;
You likely can't join if
- 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...
- Other serious or poorly controlled concomitant diseases, including but not limited to (1) Severe or acute attack disease history of cardiovascular...
See the full eligibility criteria
- 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 how well it works 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.