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2023-03-08
2024-07-08
2025-09-08
92
NCT05795920
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
INTERVENTIONAL
Utidelone Injection Combined With Gemcitabine in First-line Chemotherapy for Unresectable Advanced Pancreatic Cancer
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 Purpose:To 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 v1.1 criteria.
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 patients.Patients who met the entry criteria received Utidelone in combination with gemcitabine: Utidelone (utidelone ®) injection: 30 mg/m2, administered daily on Days 1-5, in 21-day cycles; gemcitabine: 1000 mg/m2, 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 death.Tumor 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 (RECISTv1.1) criteria.For patients without disease progression, tumor assessments will continue regardless of whether or not the patient discontinues study treatment unless consent is withdrawn.Follow-up data collection, including subsequent anticancer therapy, was to occur until patient death, withdrawal of consent, loss to follow-up, or study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 first.Safety 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) v5.0 in the Investigator-Initiated Clinical Trial (IIT) Study UTD1-PC-01 14 in Shanghai First People 's Hospital.Laboratory safety assessments included periodic monitoring of hematology and chemistry.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-03-07 | N/A | 2023-03-21 |
2023-03-21 | N/A | 2023-04-03 |
2023-04-03 | N/A | 2023-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Patients with advanced pancreatic cancer that is inoperable and not suitable for local treatment Patients with advanced pancreatic cancer that is inoperable and not suitable for local treatment | DRUG: Utidelone injection in combination with gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| overall survival | Time from enrollment to death (from any cause) | From date of randomization until the date of death from any cause assessed up to 100 months |
| progression free survival progression free survival | Disease progression from baseline assessment of enrollment to first radiographically verifiable disease progression (PD) (RECIST 1.1 standard) or deaths from any cause where progression was not recorded Time. | From date of randomization until the date of first documented progression assessed up to 100 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Duration of response Duration of Response | That is, from the first time the evaluation results meet CR or PR criteria to the observation of PD or death | Time from complete response/partial response (CR/PR) to progression/death (from any cause), assessed up to 100 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Qi Li, Prof. Phone Number: +86-13818207333 Email: leeqi2001@hotmail.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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