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

NCT03585062 | Terminated Phase 2 DMC

• 1 other identifier: 2017KY007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer; Neoadjuvant Chemotherapy

Keywords

S-1; Paclitaxel-albumin; Unresectable Pancreatic Cancer; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  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 Outcomes (4)

• The objective remission rate (ORR)

  at the end of cycle 6 of the neoadjuvant chemotherapy((each cycle is 21 days)

• The disease free survival (DFS)

  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

  2 years and 5 years after treatment

• The quality of life

  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.

Study Arms (1)

S-1 combined with Paclitaxel-albumin

EXPERIMENTAL

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,; Drug: Paclitaxel-albumin

Interventions

S1, DRUG

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

Also known as: Gimeracil and Oteracil Porassium Capsules

S-1 combined with Paclitaxel-albumin

Paclitaxel-albumin DRUG

Paclitaxel-albumin is a drug which showed a survival benefit in Pancreatic Cancer when combined with S1

S-1 combined with Paclitaxel-albumin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed invasive ductal adenocarcinoma of pancreas by histology
• Evaluated as CT4N0M0 pancreatic cancer patients by Image testing
• Adults age from 18-80 years old
• No history of pancreatic resection or pancreatic cancer
• ECOG score 0-1; can be orally administered
• No distant metastasis or malignant ascites
• 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
• Sign the Informed consent -

You may not qualify if:

• Woman in pregnant or lactation period
• 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.
• Men and women who had sexual life (Fertility possibility) were reluctant to have contraception during the study period.
• Patients with the history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
• 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
• 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.
• Patients with upper gastrointestinal obstruction or Abnormal physiological function or Malabsorption syndrome, which may affect the absorption of S-1.
• Organ transplant patients who need immunosuppressive therapy
• Patients with Serious uncontrolled repeated infection or other serious uncontrolled Concomitant disease.
• Patient that is lack of dihydropyrimidine dehydrogenase (DPD)
• Allergic to any of the drug ingredients in this study
• participate in other clinical trials within 4 weeks before randomization -

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang procincial people's hospital

Hanzhou, Zhejiang, 310014, China

Location

Related Publications (4)

• Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

  PMID: 23335087 BACKGROUND

• Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

  PMID: 21296855 BACKGROUND

• Witkowski ER, Smith JK, Tseng JF. Outcomes following resection of pancreatic cancer. J Surg Oncol. 2013 Jan;107(1):97-103. doi: 10.1002/jso.23267. Epub 2012 Sep 18.

  PMID: 22991309 BACKGROUND

• Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Buchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. doi: 10.1056/NEJMoa032295.

  PMID: 15028824 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

S 1 (combination); gimeracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Present of Zhejiang Provincial People's Hospital

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: July 12, 2018
• Study Start: November 20, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)