A Phase 2 interventional study of Bemalenograstim alfa in Colorectal Cancer and Pancreatic Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 2, Interventional, and Prevention
A multi-cohort, open-label, multicenter exploratory clinical study of Bemalenograstim alfa for the prevention of reduced absolute neutrophil count(ANC) in patients with colorectal cancer/pancreatic cancer following a bi-weekly chemotherapy regimen.A total of 89 patients are planned to be enrolled.
This multi-cohort, open-label, multicenter exploratory clinical study enrolled 89 patients with colorectal cancer and pancreatic cancer who were scheduled to receive at least 2 courses of a two-week chemotherapy regimen. The study was divided into two cohorts: Cohort 1 was colorectal cancer or pancreatic cancer patients receiving FOLFOXIRI or mFOLFIRINOX in combination with or without targeted drugs, and cohort 2 was colorectal cancer patients receiving FOLFIRI in combination with or without targeted drugs. Patients meeting the inclusion criteria received Bemalenograstim alfa injection (20mg/ time, subcutaneous injection) 24-48h after each course of chemotherapy, and Bemalenograstim alfa injection was used until the change of chemotherapy regimen or the fourth course of chemotherapy, whichever occurred first. After the subjects completed 2 courses of treatment, the follow-up treatment was carried out according to the diagnosis and treatment routine. Investigators need to ensure that the first course of chemotherapy is at the recommended dose; For the second to fourth course of treatment, delayed dosing or dose adjustment due to toxicity is allowed, and the chemotherapy dose is allowed to be adjusted by ±10%.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 89 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
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Adequate organ and bone marrow function meets the following criteria:
Exclusion Criteria:
Patients with colorectal cancer and pancreatic cancer(N=32)receive FOLFOXIRI or mFOLFIRINOX with or without targeted therapy. Subcutaneous injection of Bemalenograstim alfa 20mg/ time 24-48h after each cycle of chemotherapy.
Drug: Bemalenograstim alfa
Patients with colorectal cancer(N=57)receiving FOLFIRI with or without targeted therapy.Subcutaneous injection of Bemalenograstim alfa, 20mg/ time, 24-48h after each cycle of chemotherapy.
Drug: Bemalenograstim alfa
Bemalenograstim alfa,20mg, once every treatment
Also known as: F-627
The incidence of reduced absolute neutrophil count(ANC) of grade ≥3 in the first cycle of chemotherapy
The incidence of reduced absolute neutrophil count(ANC) of grade ≥3 in the first cycle of chemotherapy
Time frame: From Baseline to primary completion date, about 18 months
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University