TIP (paclitaxel + ifosfamide + cisplatin) Combined with Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer

A Single center and Single arm Study of TIP (paclitaxel + ifosfamide + cisplatin) Combine with Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Patients with locally advanced penile cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034375

Enrollment

Unknown

Registered

2020-07-04

Start date

2020-06-28

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penile Caner

Interventions

Neoadjuvant Therapy:TIP (paclitaxel + ifosfamide + cisplatin)+Nimotuzumab+Triprilimab

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male patients aged 18 to 75 years old; 2. Squamous cell carcinoma confirmed by histology and cytology; Stage: Locally advanced penile cancer; 3. No prior chemotherapy for newly diagnosed or relapsed patients; 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) at least 80g/L; White blood cell count at least 3.0x10^9/L; Neutrophil count at least 1.5x10^9/L; Platelet count at least 100x10^9/L; 7. Liver function: AST, ALT, ALP no greater than 2.5 ULN; Total bilirubin no greater than 1.5 ULN; 8. Estimated survival at least 12 months; 9. No prior serious disease history of systemic organ; 10. The participant unterstand this study procedure and sign the informed consent.

Exclusion criteria

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. Patient with other cancers 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; 4. Other serious and 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.

Design outcomes

Primary

Measure	Time frame
Pathologically Complete Response Rate (pCR);	—

Secondary

Measure	Time frame
Objective Response Rate (ORR);Progression Free Survival (PFS);Overall Survival (OS);Safety;	—

Countries

China

Contacts

Public ContactHui Han

Sun Yat-sen University Cancer Center

hanhui@sysucc.org.cn+86 13002018798

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026