Efficacy and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor in Secondary Prevention of Albumin Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer

NCT04239001 | Unknown

• 1 other identifier: CSPC -JYL-PC-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, open, one-arm clinical study to evaluate the efficacy and safety of jinyouli in the first-line treatment of advanced pancreatic cancer with albumin paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: albumin paclitaxel, 120mg / m2, intravenous infusion for 30 minutes, D1. S-1, taken orally after meal, D1 - 14. (2) patients who met the input / discharge criteria were given jinyouli injections 24 hours after the end of intravenous infusion of albumin paclitaxel during the treatment period.

Conditions

Advanced Pancreatic Cancer

Keywords

PEG-rhG-CSF

Outcome Measures

Primary Outcomes (1)

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

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

  It lasts 4 cycles(each cycle is 21 days)

Secondary Outcomes (4)

• The incidence of febrile neutropenia in each cycle of chemotherapy

  It lasts 4 cycles(each cycle is 21 days)

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

  It lasts 4 cycles(each cycle is 21 days)

• The proportion of patients hospitalized due to neutropenia

  It lasts 4 cycles(each cycle is 21 days)

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

  It lasts 4 cycles(each cycle is 21 days)

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

Jin Youli(PEG-rhG-CSF): jinyouli injection 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

Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSF DRUG

24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, patients with pancreatic cancer who met the input / discharge criteria were given secondary prophylactic administration of the tested drug PEG-rhG-CSF.

PEG-rhG-CSF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Age ≥ 18 years, ≤70 years;
• (2) Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
• (3) Neutropenia of ≥2 degree occurred with the albumin paclitaxel + S-1 regimen in the previous cycle.
• (4) KPS score≥70points;
• (5) The peripheral blood routine of the patients was normal: ANC ≥ 2.0x109 / L, platelet count ≥ 90 × 109 / L, HB ≥ 80g / L before enrollment, and there was no bleeding tendency;
• (6) Patients volunteered to participate in the trial and signed a written informed consent to be followed up.

You may not qualify if:

• (1) There are currently hard-to-control infections or systemic antibiotic treatment within 72 h of chemotherapy；
• (2) Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
• (3) Patients who had received bone marrow or hematopoietic stem cell transplantation within the previous 3 months；
• (4) Previous patients with other malignant tumors not cured, or brain metastases；
• (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are \>2.5 times the upper limit of normal, if the above indicators are \>5 times due to liver metastasis Upper limit of normal value;
• (6) Renal function test: serum creatinine (Cr) exceeded the upper limit of normal value；
• (7) Allergic to this product or other biological products derived from genetically engineered escherichia coli；
• (8) Suffering from a mental or nervous system disorder, lacking self-awareness or coordination；
• (9) Patients who are expected to have a short survival and have difficulty tolerating chemotherapy；
• (10) Pregnant and nursing female patients；
• (11) People who are using other drugs of the same category or are in clinical trials of other drugs；
• (12) The investigator judges patients who are not suitable for participation.

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital First medical center

Beijing, China

RECRUITING

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor

Study Officials

• Guanghai Dai

  Chinese PLA General Hospital First medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guanghai Dai

CONTACT

13801232381; daigh60@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 23, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

CN (1)