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

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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.