Status:
UNKNOWN
PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
PEG-rhG-CSF
Pancreatic Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 18 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04518800
Start Date
August 18 2020
End Date
February 18 2022
Last Update
August 19 2020
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853