Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04242927
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent obtained prior to performing any protocol-related procedures, including blood serum collecting
* HFSR grade 2 or higher after treatment with VEGFR inhibitors (such as sorafenib, regorafenib, anlotinib, and apatinib), according to NCI CTCAE V5.0 - PPE
* Age from 18 to 75 years.
* Life expectancy of at least 3 months at Day 1
Exclusion Criteria:
* History of allergy to B vitamins
* Major surgery or severe traumatic injury, fracture within 4 weeks prior to first dose of nicotinic acid or ulceration and any factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction
* Patient who takes isoniazid in combination with sorafenib and other VEGFR inhibitors.
* History of psychiatric drugs substance abuse and fails to quit it or has amental disorder
* Pregnant or nursing women, fertile patient who is unwilling or unable to use effective contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04242927
Study Brief:
Protocol Section:
NCT04242927