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

CSPC Pharmaceutical Group

Status: Unknown

Conditions: Advanced Pancreatic Cancer

Treatments: Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Industry

Identifiers

NCT04239001

CSPC -JYL-PC-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (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.

Exclusion criteria

• (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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

PEG-rhG-CSF

Experimental group

Description:

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

Treatment:

Drug: PEG-rhG-CSF