PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04518800
• Other study ID #: CSPC-JYL-PC-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 18, 2020
• Est. completion date: February 18, 2022

Study information

• Verified date: August 2020
• Source: Chinese PLA General Hospital
• Contact: Guanghai Dai, PhD.
• Phone: 13801232381
• Email: daigh60[@]sohu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 18, 2022
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• PEG-rhG-CSF

Intervention

Drug:
• Jin Youli(PEG-rhG-CSF)
Jin Youli(PEG-rhG-CSF) 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

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of degree 3-4 neutropenia in each cycle of chemotherapy	Incidence of degree 3-4 neutropenia in each cycle of chemotherapy	last 4 cycles(each cycle is 21 days)
Secondary	The incidence of febrile neutropenia in each cycle of chemotherapy	Febrile neutropenia (FN) is defined as oral temperature >38.3? or continuous measurement of oral temperature >38.1? in 1h, with ANC <0.5×10^9/L or expected to be <0.5×10^9/L	last 4 cycles(each cycle is 21 days)
Secondary	Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy	Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy	last 4 cycles(each cycle is 21 days)
Secondary	The proportion of patients hospitalized due to neutropenia	The proportion of patients hospitalized due to neutropenia	last 4 cycles(each cycle is 21 days)
Secondary	The proportion of patients receiving antibiotics during the entire chemotherapy period.	The proportion of patients receiving antibiotics during the entire chemotherapy period.	last 4 cycles(each cycle is 21 days)