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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Cancer; PEG-rhG-CSF
• Intervention / Treatment: Drug: Jin Youli(PEG-rhG-CSF)

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• 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: Jin Youli(PEG-rhG-CSF); 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).	Drug: Jin Youli(PEG-rhG-CSF); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy	Incidence of degree 3-4 neutropenia in each cycle of chemotherapy	last 4 cycles(each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	last 4 cycles(each cycle is 21 days)
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy	Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy	last 4 cycles(each cycle is 21 days)
The proportion of patients hospitalized due to neutropenia	The proportion of patients hospitalized due to neutropenia	last 4 cycles(each cycle is 21 days)
The proportion of patients receiving antibiotics during the entire chemotherapy period.	The proportion of patients receiving antibiotics during the entire chemotherapy period.	last 4 cycles(each cycle is 21 days)

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Guanghai Dai, PhD., Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 18, 2020
• Primary Completion (Anticipated): August 18, 2021
• Study Completion (Anticipated): February 18, 2022

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; PEG-rhG-CSF; Secondary Prevention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CSPC-JYL-PC-01

Drug and device information, study documents

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