Clinical trial · Interventional
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
- 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, 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| PEG-rhG-CSF | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Jin Youli(PEG-rhG-CSF) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Jin Youli(PEG-rhG-CSF)
- description
- 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).
- interventionNames
- Drug: Jin Youli(PEG-rhG-CSF)
Primary outcomes (1)
- measure
- Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
- timeFrame
- last 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
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available