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TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma

Phase 2
Active, not recruiting
Conditions
Pancreas Cancer
Interventions
Drug: TAS 102
Registration Number
NCT04923529
Lead Sponsor
The University of Hong Kong
Brief Summary

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.

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).

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
28
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

  9. Have life expectancy ≥ 3 months

  10. Adequate organ function as defined as:

    1. Hemoglobin value of ≥9.0 g/dL.
    2. Absolute neutrophil count of ≥1,500/mm3 (IU: ≥1.5 × 10^9/L).
    3. Platelet count ≥100,000/mm3 (IU: ≥100 × 10^9/L).
    4. Total serum bilirubin of ≤1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a medical diagnosis of Gilbert's syndrome).
    5. 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.
    6. Serum creatinine of ≤1.5 mg/dL
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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.
    9. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
    10. Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
    11. Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.

  3. Has had treatment with any of the following within the specified time frame prior to study drug administration:

    1. Major surgery within prior 4 weeks.
    2. Any systemic therapy within prior 2 weeks.
    3. Any radiation within prior 2 weeks.
    4. Any investigational agent received within prior 4 weeks.

  4. Untreated active hepatitis B or hepatitis C infections.

  5. Has received TAS-102.

  6. 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).

  7. Is a pregnant or lactating female.

  8. Is inappropriate for entry into this study in the judgment of the Investigator.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
TAS-102TAS 102Single group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma
Primary Outcome Measures
NameTimeMethod
16-week progression-free survival (PFS) rateFrom the date of informed consent to radiographically documented progression according to RECIST 1.1, assessed up to 16 weeks

The percentage of study population alive and without progression (according to RECIST 1.1) at 16 weeks from the date of informed consent

Secondary Outcome Measures
NameTimeMethod
Time to progression (TTP)from the date of informed consent to radiographically documented progression according to RECIST 1.1, assessed up to 3 years

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

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

The percentage of patients with radiologically complete response, partial response, or stable disease as determined by the Investigators according to RECIST version 1.1

Time to deterioration of ECOG performance statusfrom the date of informed consent to the first date on which ECOG performance status scores 2 or higher, assessed up to 3 years

Time from date of informed consent until the first date on which ECOG performance status score of 2 or higher was recorded

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

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.

Incidence of Study-Related Adverse Events [Safety and Tolerability]from the date of first study treatment to occurrence of study-related adverse events based on NCI-CTCAE 5, assessed up to 3 years

Incidence, nature, and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5)

Overall survival (OS)from the date of informed consent to the date of death from any cause, assessed up to 5 years

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

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

The percentage of patients with radiologically complete or partial response as determined by the Investigator according to RECIST version 1.1.

Duration of response (DoR)from the date of documentation of tumor response to radiographically documented progression according to RECIST 1.1, assessed up to 3 years

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

Time to deterioration of quality of lifefrom the date of informed consent to recorded decrease of 10 points or more in EORTC QLQ-C30 assessment, assessed up to 3 years

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

Trial Locations

Locations (1)

Department of Clinical Oncology, HKU

🇭🇰

Hong Kong, Hong Kong

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