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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217096
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

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.

Condition or disease Intervention/treatment Phase
Advanced Pancreatic Cancer Drug: Paclitaxel liposome Drug: S-1 Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217096


Contacts
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Contact: Xian-Jun Yu, M.D., Ph.D. +86 21 64175590 yuxianjun@fudanpci.org

Locations
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China
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China
Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xian-Jun Yu, M.D., Ph.D. Fudan University
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Responsible Party: Xian-Jun Yu, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT04217096    
Other Study ID Numbers: CSPAC-21
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action