Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer

Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer

This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable .

Study Overview

• Status: Not yet recruiting
• Conditions: Locally Advanced Pancreatic Cancer
• Intervention / Treatment: Drug: Nab-paclitaxel and S-1

Detailed Description

This single-arm, Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable . Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.

During the study, if the subject's weight change was ≤10% from baseline, the dose was calculated based on the measured value at baseline. If the change was >10%, the body surface area of the subject should be recalculated and the dose administered should be adjusted. .

Study treatment period Borderline resectable: According to the results of imaging examination, MDT discussed to determine the surgical resectability and timing of surgery. The chemotherapy time was 4-6 cycles.

Unresectable: Chemotherapy for up to 6 cycles. According to the results of imaging examination, MDT determined the resectability of the operation. It was decided by the investigator and the patient to continue chemotherapy (S-1 maintenance), surgery or radiotherapy.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhou Aiping

Study Locations

• China
  • Beijing, China
    • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient compliance is good, the research process of this study can be understood, and written informed consent is signed;
• Age ≥ 18 years old, ≤ 75 years old;
• Histologically or cytologically confirmed pancreatic adenocarcinoma；
• no prior treatment;
• Based on imaging findings, MDT decided patients intoborderline resectable (group A) or unresectable (group B) (according to the resectability assessment criteria in the 2018 Pancreatic Cancer Comprehensive Care Guidelines);
• ECOG<2;
• Bone marrow function: hemoglobin (HGB) ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets (PLT) ≥ 100 × 109 / L;
• Liver function: ALT, AST ≤ 2.5 × upper limit of normal (ULN), if there is liver metastasis, ALT, AST ≤ 5 × ULN; serum total bilirubin < 1.5 × ULN;
• Renal function: serum creatinine is within normal range;
• Patients without biliary obstruction, patients requiring biliary stent implantation must be completed at least 7 days prior to enrollment;
• Non-pregnant and lactating women, women of reproductive age/male should take effective contraceptive measures during the study period and within 6 months after the end of the study treatment;
• No contraindication to the use of S-1and albumin-bound paclitaxel.

Exclusion Criteria:

• Patients who have had other malignant tumors within 5 years (except for cured cervical cancer in situ or non-melanoma skin cancer);
• Interstitial pneumonia or pulmonary fibrosis;
• Severe pleural effusion or ascites;
• Watery diarrhea;
• There are serious concomitant diseases: such as HIV-positive,chronic HBV/HCV in active period, people who have diabetes and poorly controlled by hypoglycemic drugs, clinically severe (ie, active) heart disease, uncontrolled epilepsy, central nervous system disease or mental disorder;
• Current or previous patients with grade II peripheral neuropathy;
• Abnormal digestive tract or metabolic function, which may affect the s-1 absorber;
• Participated in other clinical researchers within 4 weeks prior to enrollment;
• Patients who have undergone organ transplantation;
• Patients considered by the investigator to be unfit for this trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experiment group; Nab-paclitaxel+S-1	Drug: Nab-paclitaxel and S-1; Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PFS	up to 2.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival rate	2 years
R0 resection rate	6 months
Overall survival	up to 2.5 years
Adverse reaction rate	up to 2.5 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Zhou Aiping, National Cancer Center/Cancer Hospital, China

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): October 2, 2023

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: CSPC-KAL-PC-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No