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

Phase 4

• Conditions: Advanced Pancreatic Cancer
• Interventions: Drug: Paclitaxel liposome; Drug: S-1

• Registration Number: NCT04217096
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-12-31
• Status Verified: 2020-01
• Study Start: 2020-01-01
• Study First Submitted QC: 2020-01-01
• Last Update Submitted: 2020-01-01
• Study First Posted: 2020-01-03
• Last Update Posted: 2020-01-03
• Primary Completion: 2022-09-30
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paclitaxel liposome + S-1	Paclitaxel liposome	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）
paclitaxel liposome + S-1	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）

Primary Outcome Measures

Name	Time	Method
Progression free survival	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

Name	Time	Method
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	To evaluate the Overall Response Rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
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	To evaluate the overall survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
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	To evaluate the disease control rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
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	To evaluate the Quality of Life of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
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	To evaluate the adverse events of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.

Trial Locations

Locations (1)

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