Clinical trial · Interventional
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
Prospective, Open, One-arm Clinical Study Evaluating the 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-rhG-CSF
- 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
- interventionNames
- Drug: PEG-rhG-CSF
Primary outcomes (1)
- measure
- Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
- timeFrame
- It lasts 4 cycles(each cycle is 21 days)
- description
- Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
Secondary outcomes (4)
- measure
- The incidence of febrile neutropenia in each cycle of chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available