Penile CancerPhase 2NCT06415318
TIP Regimen Combined With Toripalimab Neoadjuvant Therapy for Locally Advanced Penile Cancer
A Phase 2 study testing Paclitaxel + Ifosfamide + Cisplatin & Toripalimab in people with Penile Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Penile Cancer
- What is being tested?
- Paclitaxel + Ifosfamide + Cisplatin & Toripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2024to 30 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Squamous cell carcinoma confirmed by histology or cytology;
- Clinical Stage is Locally advanced penile cancer (T4, any N stage; or any T stage, N2-3);
- No prior chemotherapy for newly diagnosed or relapsed patients or the time from the last chemotherapy to relapse should be longer than 12 months;
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Toripalimab Combined With Chemotherapy for Locally Advanced Penile Squamous Cell Carcinoma: A Multicenter Prospective, Single-arm, Phase II Clinical Trial
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
Read the detailed description
Penile cancer is a rare malignant tumor, which often occurs in the inner plate of the 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. 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 the N2-3 stage. This phase II study aims to explore an effective combination therapy for locally advanced penile cancer. 25 patients need to be enrolled.TIP \& toripalimab will be administered every 21 days until surgery, evidence of disease progression, or onset of unacceptable toxicity.
- Conditions
- Penile Cancer
- Being tested
- Paclitaxel + Ifosfamide + Cisplatin & Toripalimab
- Medical subject headings
- Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel + Ifosfamide + Cisplatin & ToripalimabDrug
Paclitaxel + Ifosfamide + Cisplatin \& Toripalimab
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Neoadjuvant Therapy TIP (Paclitaxel + Ifosfamide + Cisplatin) & Toripalimab | Experimental | Drug: Toripalimab 240mg, ivgtt, d1 Drug: Paclitaxel 175 mg/m2, ivgtt, d1 Drug: Cisplatin 25mg/m2·d, ivgtt, d1-3 Drug: Ifosfamide 1.2g/m2·d, ivgtt, d1-3 Receives: Drug: Paclitaxel + Ifosfamide + Cisplatin & Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
Measured: 6 weeks
Secondary outcomes (4)
pCR
Percentage of Participants With Pathologically Complete Response
Measured: 12 weeks
EFS
Event-free survival, EFS
Measured: 2 months
OS
Overall Survival
Measured: 6 months
Adverse events
Number of participants with treatment-related adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start31 May 2024
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415318
- Sponsor's protocol ID
- B2024-043-01
- Status last verified
- Oct 2026
- First submitted
- 10 May 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Toripalimab Combined With Chemotherapy for Locally Advanced Penile Squamous Cell Carcinoma: A Multicenter Prospective, Single-arm, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT06415318
- Acronym / sponsor ID
- B2024-043-01
- Conditions
- Penile Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Penile cancer is a rare malignant tumor, which often occurs in the inner plate of the 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. 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 the N2-3 stage. This phase II study aims to explore an effective combination therapy for locally advanced penile cancer. 25 patients need to be enrolled.TIP \& toripalimab will be administered every 21 days until surgery, evidence of disease progression, or onset of unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Neoadjuvant Therapy TIP (Paclitaxel + Ifosfamide + Cisplatin) & Toripalimab | Experimental | Drug: Paclitaxel + Ifosfamide + Cisplatin & ToripalimabDrug: Toripalimab 240mg, ivgtt, d1 Drug: Paclitaxel 175 mg/m2, ivgtt, d1 Drug: Cisplatin 25mg/m2·d, ivgtt, d1-3 Drug: Ifosfamide 1.2g/m2·d, ivgtt, d1-3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Squamous cell carcinoma confirmed by histology or cytology;
- Clinical Stage is Locally advanced penile cancer (T4, any N stage; or any T stage, N2-3);
- No prior chemotherapy for newly diagnosed or relapsed patients or the time from the last chemotherapy to relapse should be longer than 12 months;
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel + Ifosfamide + Cisplatin & ToripalimabPaclitaxel + Ifosfamide + Cisplatin \& Toripalimab | Drug | Experimental: Neoadjuvant Therapy TIP (Paclitaxel + Ifosfamide + Cisplatin) & Toripalimab |
Primary outcome
ORR
Time frame: 6 weeks
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
4 secondary outcomes
pCR
Time frame: 12 weeks
EFS
Time frame: 2 months
OS
Time frame: 6 months
Adverse events
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Penile Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
Not yet recruitingPhase 2
Sacituzumab Tirumotecan Plus Toripalimab for Advanced Penile Cancer After Platinum Chemotherapy
Penile Squamous Cell Carcinoma (PSCC), Advanced Penile Cancer
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel + Ifosfamide + Cisplatin & Toripalimab in people with Penile Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.