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

NCT04518800 | Unknown

• 1 other identifier: CSPC-JYL-PC-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

PEG-rhG-CSF; Pancreatic Cancer

Keywords

PEG-rhG-CSF; Secondary Prevention; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The incidence of febrile neutropenia in each cycle of chemotherapy

  last 4 cycles(each cycle is 21 days)

• Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy

  last 4 cycles(each cycle is 21 days)

• The proportion of patients hospitalized due to neutropenia

  last 4 cycles(each cycle is 21 days)

• The proportion of patients receiving antibiotics during the entire chemotherapy period.

  last 4 cycles(each cycle is 21 days)

Study Arms (1)

Jin Youli(PEG-rhG-CSF)

EXPERIMENTAL

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).

Drug: Jin Youli(PEG-rhG-CSF)

Interventions

Jin Youli(PEG-rhG-CSF) DRUG

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

Jin Youli(PEG-rhG-CSF)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Guanghai Dai, PhD.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guanghai Dai, PhD.

CONTACT

13801232381; daigh60@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and chief physician

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 19, 2020
• Study Start: August 18, 2020
• Primary Completion: August 18, 2021
• Study Completion: February 18, 2022
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

CN (1)