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

Fudan University1 site in 1 country40 target enrollmentJanuary 1, 2020

ConditionsAdvanced Pancreatic Cancer

InterventionsPaclitaxel liposome S-1

DrugsPaclitaxel liposome S-1

Overview

Phase: Phase 4
Intervention: Paclitaxel liposome
Conditions: Advanced Pancreatic Cancer
Sponsor: Fudan University
Enrollment: 40
Locations: 1
Primary Endpoint: Progression free survival
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

January 1, 2020

End Date

March 31, 2023

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Xian-Jun Yu

Principal Investigator

Fudan University

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years and ≤75 years;
•the patients were confirmed as locally advanced or metastatic pancreatic cancer by histopathology;
•At least one measurable objective lesion was identified based on the RECIST1.1 criteria;
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
•The expected survival after surgery ≥3 months;
•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\^
•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;
•Signed informed content obtained prior to treatment.

Exclusion Criteria

•Symptomatic ascites;
•The target disease has cerebral metastasis;
•Previously received palliative chemotherapy or other palliative systemic therapy for advanced/metastatic pancreatic cancer;
•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);
•Received surgical treatment ≤4 weeks before admission;
•Severe cancer-related cachexia and/or known weight loss \>15% occurred within one month before admission;
•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;
•Human immunodeficiency virus (HIV) or Hepatitis B Virus（HBV）、hepatitis C virus (HCV) positive with Liver dysfunction;
•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;
•History of allergy or hypersensitivity to any therapeutic ingredient;

Arms & Interventions

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）

Intervention: Paclitaxel liposome

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）

Intervention: S-1

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Overall Response Rate(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(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(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)(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(from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months)