Trial of Neoadjuvant Chemotherapy With S1 Plus Paclitaxel-albumin on Pancreatic Cancer

January 6, 2021 updated by: Yi-Ping Mou, Zhejiang Provincial People's Hospital

Clinical Trial of Neoadjuvant Chemotherapy With S1 Plus Paclitaxel-albumin in Patients With Unresectable Locally Advanced Pancreatic Cancer

The study is to evaluate the R0 resection rate of patients with unresectable locally advanced pancreatic cancer ,after treated with S-1 plus Paclitaxel-albumin as neoadjuvant chemotherapy protocols

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

  1. The incidence of pancreatic cancer in China has been increasing rapidly in recent years，but most of the pancreatic cancer patients are unresectable, whose median survival time were only 6~9 months.
  2. Studies have shown that neoadjuvant therapy improves the quality of surgery in patients with pancreatic cancer，and prolong their life.
  3. S-1 is a new generation of oral fluorouracil derivatives ,S-1 single drug as an adjuvant therapy for resectable pancreatic cancer is better than gemcitabine, and has less side effects than gemcitabine. Protein bound paclitaxel is a novel paclitaxel combined of paclitaxel and albumin by nanotechnology , which can extend free survival in patients with advanced pancreatic cancer with less side effects than gemcitabine. So S-1 combined with Paclitaxel-albumin is expected to play an important role in neoadjuvant chemotherapy in Pancreatic cancer, and may improve the rate of R0 resection in patients with unresectable locally advanced pancreatic.

STUDY DESIGN:

S-1 combined with Paclitaxel-albumin

  1. S-1:40~60mg bid, day 1~14 (S-1: BSA (Body surface area)<1.25m2, 40mg bid , 1.25m2 ≤ BSA ≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid),2 weeks and rest for 1 weeks.
  2. Paclitaxel-albumin: 125 mg/m2, intravenous infusion for 30 minutes, Day1 and Day 8.

Repeat every three weeks. for 6 cycles.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

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
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310014
        • Zhejiang procincial people's hospital

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Confirmed invasive ductal adenocarcinoma of pancreas by histology
  2. Evaluated as CT4N0M0 pancreatic cancer patients by Image testing
  3. Adults age from 18-80 years old
  4. No history of pancreatic resection or pancreatic cancer
  5. ECOG score 0-1; can be orally administered
  6. No distant metastasis or malignant ascites
  7. Relatively good liver、 kidney、heart、hematology function. Baseline blood routine and biochemical indexes of the subjects meet the following criteria: hemoglobin ≥90g/L;absolute neutrophil count(ANC)≥3.5×109/L；Platelet≥100×109/L;prothrombin time ≤1.8;partial thromboplastin time ≤1.8; ALT≤102U/L、AST≤95U/L; ALP≤2.5 times the upper limits of normal; Serum total bilirubin≤2.5 g/dL(total bilirubin ≤1.5 times the upper limit of normal (ULN)；Serum creatinine≤2.0 mg/dL； creatinine clearance rate >50 ml/min
  8. Sign the Informed consent -

Exclusion Criteria:

  1. Woman in pregnant or lactation period
  2. Woman of childbearing age who was positive at baseline pregnancy test or did not have pregnancy tests.Menopausal women must have menopause for at least 12 months before they think they are free of pregnancy.
  3. Men and women who had sexual life (Fertility possibility) were reluctant to have contraception during the study period.
  4. Patients with the history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
  5. Patients of uncontrolled epilepsy, central nervous system diseases or history of mental disorders, should be judged by the researchers whether their clinical severity hinder the signature of the informed consent or influenced patients'compliance with oral medications
  6. Clinically serious (i.e. activity) heart disease, such as symptomatic coronary heart disease , New York Heart Association (NYHA) class II or more serious congestive heart failure or serious arrhythmia which need drug intervention, or have a history of MI within the last 12 months.
  7. Patients with upper gastrointestinal obstruction or Abnormal physiological function or Malabsorption syndrome, which may affect the absorption of S-1.
  8. Organ transplant patients who need immunosuppressive therapy
  9. Patients with Serious uncontrolled repeated infection or other serious uncontrolled Concomitant disease.
  10. Patient that is lack of dihydropyrimidine dehydrogenase (DPD)
  11. Allergic to any of the drug ingredients in this study
  12. participate in other clinical trials within 4 weeks before randomization -

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-1 combined with Paclitaxel-albumin
S-1 combined with Paclitaxel-albumin S-1:40~60mg bid, day 1~14 (S-1: BSA <1.25m2, 40mg bid , 1.25m2 ≤ BSA ≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid， for 2 weeks, rest a week) Paclitaxel-albumin: 125 mg/m2, intravenous infusion for 30 minutes, Day1 and Day 8.
Drug: S1,
S-1 is a combination of tegafur, gimeracil and oteracil at a molar ratio of 1:0.4:1, and is a new oral fluoropyrimidine anticancer agent shown to be effective for pancreatic cancer. cancer
Other Names:
  • Gimeracil and Oteracil Porassium Capsules
Drug: Paclitaxel-albumin
Paclitaxel-albumin is a drug which showed a survival benefit in Pancreatic Cancer when combined with S1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: one week After the operation
Evaluate the R0 resection rate of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
one week After the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The objective remission rate (ORR)
Time Frame: at the end of cycle 6 of the neoadjuvant chemotherapy((each cycle is 21 days)
Evaluate the objective remission rate (ORR) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
at the end of cycle 6 of the neoadjuvant chemotherapy((each cycle is 21 days)
The disease free survival (DFS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months. Progressing should be confirmed by imaging examination or histology / cytology examination.
Evaluate the disease free survival (DFS) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months. Progressing should be confirmed by imaging examination or histology / cytology examination.
The 2 year and 5 year survival rate
Time Frame: 2 years and 5 years after treatment
Evaluate the 2 year and 5 year survival rate of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer
2 years and 5 years after treatment
The quality of life
Time Frame: Questionnaire at baseline, and then 1-2 days before each cycle of treatment(each cycle is 21 days, for a total of 6 cycles.). During follow-up period after treatment, questionnaire every 6 months, up to 2 years.
Assess the quality of life in pancreatic cancer according to EORTC QLQ-PAN26(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreas 26).For each assessment item, there are four options, scores are as 1,2,3,4. Each score corresponds to a physical condition. Then have the total score for each patient. The total score range from 26-104, the higher the score, the poorer the quality of life is.
Questionnaire at baseline, and then 1-2 days before each cycle of treatment(each cycle is 21 days, for a total of 6 cycles.). During follow-up period after treatment, questionnaire every 6 months, up to 2 years.

Collaborators and Investigators

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

Sponsor

Zhejiang Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 20, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

July 1, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017KY007

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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