Clinical trial · Interventional
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) Combined With Nimotuzumab & Triprilimab as Neoadjuvant Treatment in Locally Advanced Penile Cancer
NCT04475016CI-TRIAL-00059008completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective:To evaluate the efficacy and safety of TIP (paclitaxel + ifosfamide + cisplatin) combined with nimotuzumab \& triprilimab as neoadjuvant treatment in locally advanced penile cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-Bound Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| Triprilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Therapy
- description
- TIP (Paclitaxel + Ifosfamide + Cisplatin) \& Nimotuzumab \& Triprilimab
- interventionNames
- Drug: Albumin-Bound Paclitaxel
- Drug: Ifosfamide
- Drug: Cisplatin
- Drug: Nimotuzumab
- Drug: Triprilimab
Primary outcomes (1)
- measure
- Percentage of Participants With Pathologically Complete Response
- timeFrame
- 12 weeks
- description
- Histopathologic assessment for patients undergoing surgical resection followed by 4 cycles of neoadjuvant treatment. Pathologically complete response is defined as the absence of noninvasive tumor residuals in inguinal lymph node and pelvic lymph node after neoadjuvant chemotherapy as assessed by American Joint Committee on Cancer (AJCC) staging version 8.0.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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; 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 systemic organ; 10. The participant unterstand this study procedure and sign 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 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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.