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

Primary Purpose

Locally Advanced Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nab-paclitaxel and S-1

About this trial

This is an interventional treatment trial for Locally Advanced Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experiment group

Arm Description

Nab-paclitaxel+S-1

Outcomes

Primary Outcome Measures

PFS

Secondary Outcome Measures

R0 resection rate

Overall survival rate

Overall survival

Adverse reaction rate

Full Information

NCT ID

NCT03815461

First Posted

January 23, 2019

Last Updated

January 24, 2019

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03815461

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2019 (Anticipated)

Primary Completion Date

June 1, 2023 (Anticipated)

Study Completion Date

October 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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 .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experiment group

Arm Type

Experimental

Arm Description

Nab-paclitaxel+S-1

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel and S-1

Intervention Description

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.

Primary Outcome Measure Information:

Title

PFS

Time Frame

up to 2.5 years

Secondary Outcome Measure Information:

Title

R0 resection rate

Time Frame

6 months

Title

Overall survival rate

Time Frame

2 years

Title

Overall survival

Time Frame

up to 2.5 years

Title

Adverse reaction rate

Time Frame

up to 2.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhou Aiping

Phone

+86 13691161998

zhouap1825@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhou Aiping

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhou Aiping

Organizational Affiliation

National Cancer Center/Cancer Hospital, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Beijing

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhou Aiping

Phone

+86 13691161998

zhouap1825@126.com

12. IPD Sharing Statement

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

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