TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

NCT04923529 | Completed Phase 2

• 1 other identifier: UW 20-711
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreas Cancer

Keywords

Pancreatic Adenocarcinoma; TAS-102

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Progression-free Survival (PFS)

  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)

  from the date of informed consent to radiographically documented progression according to RECIST 1.1, assessed up to 3 years

• Overall survival (OS)

  from the date of informed consent to the date of death from any cause, assessed up to 5 years

• Objective response rate (ORR)

  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)

  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

Study Arms (1)

TAS-102

EXPERIMENTAL

Single group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma

Drug: TAS 102

Interventions

TAS 102 DRUG

Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. Days 6 through 7: Recovery Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12. Days 13 through 28: Recovery

TAS-102

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological confirmed advanced or metastatic pancreatic cancer
• Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease
• Documented progression after one or more lines of systemic chemotherapy
• For the treatment of advanced or metastatic disease
• Within 6 months after completion of neo-adjuvant therapy or adjuvant therapy
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance 0-1
• Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available
• Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
• Females of childbearing potential must have negative serum or urine pregnancy test
• Have life expectancy ≥ 3 months
• Adequate organ function as defined as:
• Hemoglobin value of ≥9.0 g/dL.
• Absolute neutrophil count of ≥1,500/mm3 (IU: ≥1.5 × 10\^9/L).
• Platelet count ≥100,000/mm3 (IU: ≥100 × 10\^9/L).

You may not qualify if:

• Has disease that is suitable for local therapy administrated with curative intent
• Has a serious illness or medical condition(s) including, but not limited to the following:
• Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
• Known brain metastasis or leptomeningeal metastasis.
• Active infection (i.e. body temperature ≥38°C due to infection).
• Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
• Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder.
• Uncontrolled diabetes.
• Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
• Gastrointestinal hemorrhage.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
• Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
• Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
• Has had treatment with any of the following within the specified time frame prior to study drug administration:
• Major surgery within prior 4 weeks.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Department of Clinical Oncology, HKU

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Chi Leung Chiang, FRCR

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 11, 2021
• Study Start: March 1, 2021
• Primary Completion: March 25, 2024
• Study Completion: December 31, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

HK (1)