- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2021-03-01
2024-03-25
2024-12-31
28
NCT04923529
The University of Hong Kong
The University of Hong Kong
INTERVENTIONAL
TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma
This study is a prospective phase II, single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of TAS 102 in advanced or metastatic pancreatic cancer patients.
All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number).
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 |
|---|---|---|
2021-06-06 | N/A | 2024-07-14 |
2021-06-06 | N/A | 2024-07-16 |
2021-06-11 | N/A | 2024-07 |
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: TAS-102 Single group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma | DRUG: TAS 102
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 16-week progression-free survival (PFS) rate | The percentage of study population alive and without progression (according to RECIST 1.1) at 16 weeks from the date of informed consent | From the date of informed consent to radiographically documented progression according to RECIST 1.1, assessed up to 16 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is measured from the date of informed consent to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow up will be censored at the date of their last radiographic assessment. | from the date of informed consent to radiographically documented progression according to RECIST 1.1 or death from any cause, whichever occurs first, assessed up to 3 years |
| Time to progression (TTP) | TTP is measured from the date of informed consent to radiographically documented progression according to RECIST 1.1. Participants death and without disease progression, alive without disease progression, or lost to follow-up will be censored at the date of their last radiographic assessment | from the date of informed consent to radiographically documented progression according to RECIST 1.1, assessed up to 3 years |
| Overall survival (OS) | OS is measured from date of informed consent to the date of death from any cause. Participants alive or lost to follow-up will be censored at the date of their last radiographic assessment | from the date of informed consent to the date of death from any cause, assessed up to 5 years |
| Objective response rate (ORR) | The percentage of patients with radiologically complete or partial response as determined by the Investigator according to RECIST version 1.1. | From the date of first study treatment to radiographically documented complete response or partial response according to RECIST 1.1, assessed up to 3 years |
| Disease control rate (DCR) | The percentage of patients with radiologically complete response, partial response, or stable disease as determined by the Investigators according to RECIST version 1.1 | from the date of first study treatment to radiographically documented complete response, partial response, or stable disease according to RECIST 1.1, assessed up to 3 years |
| Duration of response (DoR) | DoR is the time from documentation of tumor response to radiographically documented disease progression | from the date of documentation of tumor response to radiographically documented progression according to RECIST 1.1, assessed up to 3 years |
| Time to deterioration of ECOG performance status | Time from date of informed consent until the first date on which ECOG performance status score of 2 or higher was recorded | from the date of informed consent to the first date on which ECOG performance status scores 2 or higher, assessed up to 3 years |
| Time to deterioration of quality of life | Decrease from baseline of 10 points or more on the EORTC QLQ-C30 maintained for two consecutive assessments or a decrease of 10 points or more in one assessment followed by death from any cause within 3 weeks | from the date of informed consent to recorded decrease of 10 points or more in EORTC QLQ-C30 assessment, assessed up to 3 years |
| Incidence of Study-Related Adverse Events [Safety and Tolerability] | Incidence, nature, and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5) | from the date of first study treatment to occurrence of study-related adverse events based on NCI-CTCAE 5, assessed up to 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
