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RECRUITING
NCT06684327
PHASE2

Multi-cohort, Single-arm Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin in the Treatment of Rare Advanced Tumors

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if albumin-paclitaxel, ifosfamide and cisplatin (Nab-TIP) works to treat advanced rare tumors including PAGET's disease of scrotum with infiltrating sweat gland carcinoma (cohort 1), rhabdomyosarcoma (cohort 2), testicular cancer (cohort 3), penile cancer (cohort 4), and urachus cancer (cohort 5) . It will also learn about the safety of Nab-TIP. The main questions it aims to answer are: Does Nab-TIP improve the objective response rate and prolong the survival of participants? What medical problems do participants have when receiving the regimen of Nab-TIP? Participants will: Receive albumin-paclitaxel 260mg/m2 d1, isocyclophosphamide 1500mg/m2 d2-5, and cisplatin 25mg/m2 d2-5 every 21 days until disease progression, intolerable toxicity, or full 6 cycles of treatment, whichever occurs first. Be performed imaging evaluation according to RECIST 1.1 every 6 weeks for 1 year of treatment and every 12 weeks after 1 year Be recorded any adverse events in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-11-30

Completion Date

2027-12-30

Last Updated

2024-12-20

Healthy Volunteers

No

Interventions

DRUG

Albumin-paclitaxel Injection

Participant will receive albumin-paclitaxel 260mg/m2 d1, isocyclophosphamide 1500mg/m2 d2-5, and cisplatin 25mg/m2 d2-5 every 21 days until disease progression, intolerable toxicity, or full 6 cycles of treatment, whichever occurs first.

Locations (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China