Efficacy and Safety of Paclitaxel Liposome and S-1 as First-line Therapy in \ Advanced Pancreatic Cancer Patients

January 1, 2020 updated by: Xian-Jun Yu, Fudan University

A Single-arm, Prospective Study to Evaluate the Efficacy and Safety of the Combination of Paclitaxel Liposome and S-1 as First-line Therapy in Treating Patients With Advanced Metastatic Pancreatic Cancer

The present study is intended to investigate the efficacy and safety of the patients with confirmed advanced pancreatic cancer after treating with the combination of paclitaxel liposome plus S-1.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Masking: Open Lable Primary Purpose: Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 years and ≤75 years;
  2. the patients were confirmed as locally advanced or metastatic pancreatic cancer by histopathology;
  3. At least one measurable objective lesion was identified based on the RECIST1.1 criteria;
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  5. The expected survival after surgery ≥3 months;
  6. Adequate liver/kidney/bone marrow function： Absolute neutrophil count (ANC) ≥1.5×10^9/L; Hemoglobin (Hgb) ≥9g/dL; Platelets (PLT) ≥100×10^9/L; Total bilirubin (TBIL) ≤1.5×ULN; Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤2.5×institutional upper limit of normal (ULN), or ≤5×ULN(hepatic metastases); Serum creatinine level is normal or creatinine clearance rate≥60 mL/min/1.73 m^2.
  7. Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 7 days before the start of chemotherapy、during the monthly treatment interval and after the last treatment;
  8. Signed informed content obtained prior to treatment.

Exclusion Criteria:

  1. Symptomatic ascites;
  2. The target disease has cerebral metastasis;
  3. Previously received palliative chemotherapy or other palliative systemic therapy for advanced/metastatic pancreatic cancer;
  4. Previously received treatments based on paclitaxel liposomes or S-1, except for neoadjuvant therapy or adjuvant therapy (before and after R0/R1 excision), which was based on paclitaxel liposomes or S-1(the time of discontinuation of neoadjuvant/adjuvant chemotherapy before admission ≥6 months);
  5. Received surgical treatment ≤4 weeks before admission;
  6. Severe cancer-related cachexia and/or known weight loss >15% occurred within one month before admission;
  7. The medical history and complications, which may affect patients' ability to participate in the study and their safety during the study, or interfere with explanation of the study results, for example: uncontrolled hypertension, cardiovascular and cerebrovascular diseases such as cerebrovascular accident (≤6 months from the start of the study), myocardial infarction (≤less than 6 months from the start of the study), unstable angina pectoris, heart failure (≥2 grades) (NYHA functional score), severe arrhythmia requiring medication, metabolic dysfunction, severe renal insufficiency;
  8. Human immunodeficiency virus (HIV) or Hepatitis B Virus（HBV）、hepatitis C virus (HCV) positive with Liver dysfunction;
  9. Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of admission, excepted cured carcinoma in situ of cervix、basal cell carcinoma of the skin;
  10. History of allergy or hypersensitivity to any therapeutic ingredient;
  11. Patients with known active alcohol or drug abuse or dependence;
  12. Pregnancy, or women who are currently trying to conceive, or who are likely to have children and do not use contraceptives, or breastfeeding women;
  13. Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: paclitaxel liposome + S-1
paclitaxel liposome at 175 mg/m^2 on day 1; S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid，d1-14，q3w）
Drug: Paclitaxel liposome
Patients receive paclitaxel liposome 175 mg/m^2 (iv, 3h) on day 1 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic
Drug: S-1
Patients receive S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid）on days 1-14 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
To evaluate the Progression Free Survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
To evaluate the Overall Response Rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
overall survival
Time Frame: from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
To evaluate the overall survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Disease control rate
Time Frame: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
To evaluate the disease control rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
Quality of life (Qol)
Time Frame: from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
To evaluate the Quality of Life of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
Adverse events
Time Frame: from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months
To evaluate the adverse events of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xian-Jun Yu, M.D., Ph.D., Fudan University

Study record dates

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 Major Dates

Study Start (ANTICIPATED)

January 1, 2020

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

March 31, 2023

Study Registration Dates

First Submitted

December 31, 2019

First Submitted That Met QC Criteria

January 1, 2020

First Posted (ACTUAL)

January 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 1, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPAC-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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