Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05795920
Status:
RECRUITING
Last Update Posted:
2023-04-03
First Post:
2023-03-07
Brief Title:
Utidelone Injection Combined With Gemcitabine in First-line Chemotherapy for Unresectable Advanced Pancreatic Cancer
Sponsor:
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
A Multicenter One-arm Phase II Clinical Study of Utidelone Injection Combined With Gemcitabine in First-line Chemotherapy for Unresectable Advanced Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is an efficacy and safety evaluation of the use of Utidelone injection in combination with gemcitabine for inoperable and locally inappropriate use first-line chemotherapy in the treatment of advanced pancreatic cancer
Main PurposeTo evaluate the use of utidelone in combination with gemcitabine in unresectable advanced pancreatic cancer without progressionSurvival PFS overall survival OS duration of response DOR and safety Secondary objective Use of utidelone in combination with gemcitabine in patients with unresectable advanced pancreatic cancer according to investigators Objective response rates ORRs assessed against RECIST v11 criteria
Main PurposeTo evaluate the use of utidelone in combination with gemcitabine in unresectable advanced pancreatic cancer without progressionSurvival PFS overall survival OS duration of response DOR and safety Secondary objective Use of utidelone in combination with gemcitabine in patients with unresectable advanced pancreatic cancer according to investigators Objective response rates ORRs assessed against RECIST v11 criteria
Detailed Description:
This trial is a multicenter single-arm phase II clinical trial of Utidelone UTD1 injection combined with gemcitabine in patients with unresectable advanced pancreatic cancer and the study will include 6 centers and enroll 92 patientsPatients who met the entry criteria received Utidelone in combination with gemcitabine Utidelone utidelone injection 30 mgm2 administered daily on Days 1-5 in 21-day cycles gemcitabine 1000 mgm2 administered 3 weeks using Q3W on Days 1 and 8 in 21-day cycles treatment period 6-8 cycles or until the patient experienced disease progression or intolerable toxicity or deathTumor assessments will be performed at baseline and every 6 weeks 7 days after enrollment until disease progression according to response evaluation criteria in solid tumours RECISTv11 criteriaFor patients without disease progression tumor assessments will continue regardless of whether or not the patient discontinues study treatment unless consent is withdrawnFollow-up data collection including subsequent anticancer therapy was to occur until patient death withdrawal of consent loss to follow-up or study termination whichever came firstSafety assessments assessed the incidence nature and severity of adverse events and laboratory abnormalities according to the National Cancer Institute Common Terminology Criteria for Adverse Events NCI CTCAE v50 in the Investigator-Initiated Clinical Trial IIT Study UTD1-PC-01 14 in Shanghai First People s HospitalLaboratory safety assessments included periodic monitoring of hematology and chemistry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None