Multi-cohort, Single-arm Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin in the Treatment of Rare Advanced Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals able to understand and give written informed consent.
Stage IV disease
Adequate performance status (ECOG 0-2)
Expected survival ≥ 3 months.
Disqualifiers
1. Active or uncontrolled severe infections (≥CTCAE Level 2) requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infections.
2. Active hepatitis (transaminases not within inclusion criteria; HBV reference: HBV DNA ≥2000 IU/ml or ≥10^4 copies/ml; HCV reference: HCV RNA ≥2000 IU/ml or ≥10^4 copies/ml; after nucleoside antiviral treatment below the above standards, may be eligible; chronic HBV carrier with HBV DNA <10^4 IU/ml, must receive antiviral treatment during the study period to be eligible).
3. Renal failure requiring hemodialysis or peritoneal dialysis.
4. History of immunodeficiency, including HIV positive or having other acquired/congenital immunodeficiency diseases, or organ transplant history.
Trial design
Design model
Single group
Treatments tested in this trial
Albumin-paclitaxel Injection
DrugParticipant 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Nab-TIPExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
ORR was defined as the proportion of patients who achieved either a complete response (CR) or a partial response (PR) based on the investigator's assessment (RECIST v1.1) that was confirmed by a subsequent scan ≥4 weeks after initial CR/PR.
Time frame
12 weeksSecondary outcomes
1
Progression-free survival(PFS)
PFS was defined as the time between the enrollment and either RECIST1.1-defined progressive disease or death due to any cause, whichever occurred first.
Time frame
1 year2
Overall survival (OS)
OS was defined as the time between the enrollment and death due to any cause.
Time frame
2 yearsOther outcomes
1
Adverse events (AE)
Any adverse events will be recorded in the whole study period including type, incidence, grade, severity, duration, and association with the study drug according to NCI-CTCAE V5.0 criteria.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov