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COMPLETEDPHASE2

TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Phase II Trial of TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

NCT04923529•The University of Hong Kong

Summary

This is a prospective phase II, single arm clinical trial conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of TAS-102 in advanced or metastatic pancreatic cancer patients.

Detailed Description

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histological or cytological confirmed advanced or metastatic pancreatic cancer
•2. Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease
•3. Documented progression after one or more lines of systemic chemotherapy
•1. For the treatment of advanced or metastatic disease
•2. Within 6 months after completion of neo-adjuvant therapy or adjuvant therapy
•4. Age ≥ 18 years
•5. Eastern Cooperative Oncology Group (ECOG) performance 0-1
•6. Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available
•7. Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
•8. Females of childbearing potential must have negative serum or urine pregnancy test
+8 more criteria

Exclusion Criteria

•1. Has disease that is suitable for local therapy administrated with curative intent
•2. Has a serious illness or medical condition(s) including, but not limited to the following:
•1. Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
•2. Known brain metastasis or leptomeningeal metastasis.
•3. Active infection (i.e. body temperature ≥38°C due to infection).
•4. Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
•5. Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder.
•6. Uncontrolled diabetes.
•7. Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
•8. Gastrointestinal hemorrhage.
+13 more criteria

Locations (1)

Department of Clinical Oncology, HKU

Hong Kong, Hong Kong

Key Dates

Start Date

March 1, 2021

Primary Completion Date

March 25, 2024

Completion Date

December 31, 2024

Last Updated

July 18, 2025

Enrollment

ACTUAL participants

Conditions

Pancreas Cancer

Interventions

TAS 102

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

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