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Pancreas CancerPhase 2NCT04923529

TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

A Phase 2 study testing TAS 102 in people with Pancreas Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer
What is being tested?
TAS 102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteHong Kong
Study dates
1 Mar 2021to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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).
  • Total serum bilirubin of ≤1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a medical diagnosis of Gilbert's syndrome).
  • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤5 × ULN.
  • Serum creatinine of ≤1.5 mg/dL

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.
  • Any systemic therapy within prior 2 weeks.
  • Any radiation within prior 2 weeks.
  • Any investigational agent received within prior 4 weeks.
  • Untreated active hepatitis B or hepatitis C infections.
  • Has received TAS-102.
  • Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation and platinum-induced neurotoxicity).
  • Is a pregnant or lactating female.
  • Is inappropriate for entry into this study in the judgment of the Investigator.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Department of Clinical Oncology, HKU

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read the 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).

Conditions
Pancreas Cancer
Being tested
TAS 102
Keywords
Pancreatic Adenocarcinoma, TAS-102
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAS 102Drug

    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

Study groups in NCT04923529
Study groupRoleWhat they receive
TAS-102ExperimentalSingle group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma
Receives: Drug: TAS 102

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From the date of informed consent to radiographically documented progression according to RECIST 1.1, assessed up to 16 weeks

Secondary outcomes (9)

  1. 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.

    Measured: 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

  2. 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

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

  3. 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

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

  4. 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.

    Measured: 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

  5. 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

    Measured: 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

  6. Duration of response (DoR)

    DoR is the time from documentation of tumor response to radiographically documented disease progression

    Measured: from the date of documentation of tumor response to radiographically documented progression according to RECIST 1.1, assessed up to 3 years

  7. 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

    Measured: from the date of informed consent to the first date on which ECOG performance status scores 2 or higher, assessed up to 3 years

  8. 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

    Measured: from the date of informed consent to recorded decrease of 10 points or more in EORTC QLQ-C30 assessment, assessed up to 3 years

  9. 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)

    Measured: from the date of first study treatment to occurrence of study-related adverse events based on NCI-CTCAE 5, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start1 Mar 2021
  3. Primary completion25 Mar 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04923529
Sponsor's protocol ID
UW 20-711
Status last verified
Jul 2025
First submitted
6 Jun 2021
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PubMed 31912902

  • Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. doi: 10.1200/JCO.1997.15.6.2403.

    PubMed 9196156

  • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

    PubMed 21561347

  • Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

    PubMed 24131140

  • Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.

    PubMed 26615328

  • Oettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Gorner M, Molle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dorken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014 Aug 10;32(23):2423-9. doi: 10.1200/JCO.2013.53.6995. Epub 2014 Jun 30.

    PubMed 24982456

  • Gill S, Ko YJ, Cripps C, Beaudoin A, Dhesy-Thind S, Zulfiqar M, Zalewski P, Do T, Cano P, Lam WYH, Dowden S, Grassin H, Stewart J, Moore M. PANCREOX: A Randomized Phase III Study of Fluorouracil/Leucovorin With or Without Oxaliplatin for Second-Line Advanced Pancreatic Cancer in Patients Who Have Received Gemcitabine-Based Chemotherapy. J Clin Oncol. 2016 Nov 10;34(32):3914-3920. doi: 10.1200/JCO.2016.68.5776. Epub 2016 Sep 30.

    PubMed 27621395

  • Ioka T, Komatsu Y, Mizuno N, Tsuji A, Ohkawa S, Tanaka M, Iguchi H, Ishiguro A, Kitano M, Satoh T, Yamaguchi T, Takeda K, Kida M, Eguchi K, Ito T, Munakata M, Itoi T, Furuse J, Hamada C, Sakata Y. Randomised phase II trial of irinotecan plus S-1 in patients with gemcitabine-refractory pancreatic cancer. Br J Cancer. 2017 Feb 14;116(4):464-471. doi: 10.1038/bjc.2016.436. Epub 2017 Jan 12.

    PubMed 28081543

  • Ueno M, Okusaka T, Omuro Y, Isayama H, Fukutomi A, Ikeda M, Mizuno N, Fukuzawa K, Furukawa M, Iguchi H, Sugimori K, Furuse J, Shimada K, Ioka T, Nakamori S, Baba H, Komatsu Y, Takeuchi M, Hyodo I, Boku N. A randomized phase II study of S-1 plus oral leucovorin versus S-1 monotherapy in patients with gemcitabine-refractory advanced pancreatic cancer. Ann Oncol. 2016 Mar;27(3):502-8. doi: 10.1093/annonc/mdv603. Epub 2015 Dec 17.

    PubMed 26681680

  • Ohkawa S, Okusaka T, Isayama H, Fukutomi A, Yamaguchi K, Ikeda M, Funakoshi A, Nagase M, Hamamoto Y, Nakamori S, Tsuchiya Y, Baba H, Ishii H, Omuro Y, Sho M, Matsumoto S, Yamada N, Yanagimoto H, Unno M, Ichikawa Y, Takahashi S, Watanabe G, Wakabayashi G, Egawa N, Tsuda M, Hosotani R, Hamada C, Hyodo I. Randomised phase II trial of S-1 plus oxaliplatin vs S-1 in patients with gemcitabine-refractory pancreatic cancer. Br J Cancer. 2015 Apr 28;112(9):1428-34. doi: 10.1038/bjc.2015.103. Epub 2015 Apr 16.

    PubMed 25880004

  • Ge F, Xu N, Bai Y, Ba Y, Zhang Y, Li F, Xu H, Jia R, Wang Y, Lin L, Xu J. S-1 as monotherapy or in combination with leucovorin as second-line treatment in gemcitabine-refractory advanced pancreatic cancer: a randomized, open-label, multicenter, phase II study. Oncologist. 2014 Nov;19(11):1133-4. doi: 10.1634/theoncologist.2014-0223. Epub 2014 Oct 1.

    PubMed 25273077

  • Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A phase II trial of nab-Paclitaxel as second-line therapy in patients with advanced pancreatic cancer. Am J Clin Oncol. 2013 Apr;36(2):151-6. doi: 10.1097/COC.0b013e3182436e8c.

    PubMed 22307213

  • Ko AH, Tempero MA, Shan YS, Su WC, Lin YL, Dito E, Ong A, Wang YW, Yeh CG, Chen LT. A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer. Br J Cancer. 2013 Aug 20;109(4):920-5. doi: 10.1038/bjc.2013.408. Epub 2013 Jul 23.

    PubMed 23880820

  • Sudo K, Yamaguchi T, Nakamura K, Denda T, Hara T, Ishihara T, Yokosuka O. Phase II study of S-1 in patients with gemcitabine-resistant advanced pancreatic cancer. Cancer Chemother Pharmacol. 2011 Feb;67(2):249-54. doi: 10.1007/s00280-010-1311-3. Epub 2010 Mar 30.

    PubMed 20352216

  • Yi SY, Park YS, Kim HS, Jun HJ, Kim KH, Chang MH, Park MJ, Uhm JE, Lee J, Park SH, Park JO, Lee JK, Lee KT, Lim HY, Kang WK. Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer. Cancer Chemother Pharmacol. 2009 May;63(6):1141-5. doi: 10.1007/s00280-008-0839-y. Epub 2008 Oct 7.

    PubMed 18839175

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAS 102 in people with Pancreas Cancer, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

16-week progression-free survival (PFS) rate (time frame: From the date of informed consent to radiographically documented progression according to RECIST 1.1, assessed up to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04923529, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.

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