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PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer

Primary Purpose

PEG-rhG-CSF, Pancreatic Cancer

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Jin Youli(PEG-rhG-CSF)

About this trial

This is an interventional prevention trial for PEG-rhG-CSF focused on measuring PEG-rhG-CSF, Secondary Prevention, Pancreatic Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years, ≤70 years;
Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
Neutropenia of ≥2 degree occurred with the nab-paclitaxel + S-1 regimen in the previous cycle.
KPS score≥70;
The peripheral blood routine of the patients was normal: ANC ≥ 2.0x10^9/L, platelet count ≥ 90x10^9/L, HB ≥ 80g/L before enrollment, and there was no bleeding tendency;
Patients volunteered to participate in the trial, signed a written informed consent, willing to be followed up.

Exclusion Criteria:

There are uncontrollable infections at the moment or systemic antibiotic treatment within 72 h of chemotherapy；
Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
Patients who had received bone marrow or hematopoietic stem cell transplantation within 3 months；
Patients with other malignancies that have not been cured or with brain metastases；
Total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 ULN, or >5 ULN if there is liver metastasis;
Serum creatinine (Cr) exceeded the upper limit of normal value；
Allergic to this product or other biological products derived from genetically engineered escherichia coli；
Suffering from a mental or nervous system disorder, without self-awareness or coordination；
Patients expected to have a short survival or have difficulty tolerating chemotherapy；
Pregnant or lactating female patients；
Patients using other drugs of the same category or in clinical trials of other drugs；
Not suitable for participation at investigators' discretion.

Sites / Locations

Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Jin Youli(PEG-rhG-CSF)

Arm Description

PEG-rhG-CSF Secondary Prevention：patients with pancreatic cancer who met the eligibility criteria were given secondary prophylactic administration of the Jin Youli(PEG-rhG-CSF).

Outcomes

Primary Outcome Measures

Incidence of degree 3-4 neutropenia in each cycle of chemotherapy

Secondary Outcome Measures

The incidence of febrile neutropenia in each cycle of chemotherapy

Febrile neutropenia (FN) is defined as oral temperature >38.3℃ or continuous measurement of oral temperature >38.1℃ in 1h, with ANC <0.5×10^9/L or expected to be <0.5×10^9/L

Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy

The proportion of patients hospitalized due to neutropenia

The proportion of patients receiving antibiotics during the entire chemotherapy period.

Full Information

NCT ID

NCT04518800

First Posted

August 17, 2020

Last Updated

August 17, 2020

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04518800

Brief Title

PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer

Official Title

Prospective, Open, Single-arm Clinical Study Evaluating the Efficacy and Safety of PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 18, 2020 (Anticipated)

Primary Completion Date

August 18, 2021 (Anticipated)

Study Completion Date

February 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

A prospective, open, single-arm clinical study to evaluate the efficacy and safety of jinyouli（PEG-rhG-CSF） in the first-line treatment of advanced pancreatic cancer with nab-paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: nab-paclitaxel, 260mg/m2, intravenous infusion for 30 minutes, D1, Q3W. S-1, 80-120mg, PO BID, D1-14, Q3W. (2) patients who met the eligibility criteria were given jinyouli injections 24 hours after the end of intravenous infusion of nab-paclitaxel during the treatment period.

6. Conditions and Keywords

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

PEG-rhG-CSF, Pancreatic Cancer

Keywords

PEG-rhG-CSF, Secondary Prevention, Pancreatic Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Jin Youli(PEG-rhG-CSF)

Arm Type

Experimental

Arm Description

PEG-rhG-CSF Secondary Prevention：patients with pancreatic cancer who met the eligibility criteria were given secondary prophylactic administration of the Jin Youli(PEG-rhG-CSF).

Intervention Type

Drug

Intervention Name(s)

Jin Youli(PEG-rhG-CSF)

Intervention Description

Jin Youli(PEG-rhG-CSF) was given 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle

Primary Outcome Measure Information:

Title

Incidence of degree 3-4 neutropenia in each cycle of chemotherapy

Description

Incidence of degree 3-4 neutropenia in each cycle of chemotherapy

Time Frame

last 4 cycles(each cycle is 21 days)

Secondary Outcome Measure Information:

Title

The incidence of febrile neutropenia in each cycle of chemotherapy

Description

Febrile neutropenia (FN) is defined as oral temperature >38.3℃ or continuous measurement of oral temperature >38.1℃ in 1h, with ANC <0.5×10^9/L or expected to be <0.5×10^9/L

Time Frame

last 4 cycles(each cycle is 21 days)

Title

Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy

Description

Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy

Time Frame

last 4 cycles(each cycle is 21 days)

Title

The proportion of patients hospitalized due to neutropenia

Description

The proportion of patients hospitalized due to neutropenia

Time Frame

last 4 cycles(each cycle is 21 days)

Title

The proportion of patients receiving antibiotics during the entire chemotherapy period.

Description

The proportion of patients receiving antibiotics during the entire chemotherapy period.

Time Frame

last 4 cycles(each cycle is 21 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years, ≤70 years; Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months; Neutropenia of ≥2 degree occurred with the nab-paclitaxel + S-1 regimen in the previous cycle. KPS score≥70; The peripheral blood routine of the patients was normal: ANC ≥ 2.0x10^9/L, platelet count ≥ 90x10^9/L, HB ≥ 80g/L before enrollment, and there was no bleeding tendency; Patients volunteered to participate in the trial, signed a written informed consent, willing to be followed up. Exclusion Criteria: There are uncontrollable infections at the moment or systemic antibiotic treatment within 72 h of chemotherapy； Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function； Patients who had received bone marrow or hematopoietic stem cell transplantation within 3 months； Patients with other malignancies that have not been cured or with brain metastases； Total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 ULN, or >5 ULN if there is liver metastasis; Serum creatinine (Cr) exceeded the upper limit of normal value； Allergic to this product or other biological products derived from genetically engineered escherichia coli； Suffering from a mental or nervous system disorder, without self-awareness or coordination； Patients expected to have a short survival or have difficulty tolerating chemotherapy； Pregnant or lactating female patients； Patients using other drugs of the same category or in clinical trials of other drugs； Not suitable for participation at investigators' discretion.

Central Contact Person:

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

Guanghai Dai, PhD.

Phone

13801232381

daigh60@sohu.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guanghai Dai, PhD.

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guanghai Dai, PhD.

Phone

13801232381

daigh301@vip.sina.com

12. IPD Sharing Statement

Learn more about this trial

PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer

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