Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05022628 |
Other study ID # |
ky153 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
September 30, 2021 |
Est. completion date |
August 2024 |
Study information
Verified date |
September 2021 |
Source |
Anhui Provincial Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
For HCC patients with combined PVTT, systemic therapy can be used as a basic approach
throughout the treatment and in combination with hepatectomy, TACE, HAIC, radiotherapy, etc.
Our center proposes to conduct a clinical study of radiotherapy combined with donafinil for
neoadjuvant treatment of HCC patients with portal vein carcinoma thrombosis to observe the
safety and efficacy of donafinib combined with radiotherapy for neoadjuvant treatment
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Description:
In the pre-enrollment screening phase, investigators are required to record all screened
patients uniformly on a subject screening and enrollment form that focuses on basic patient
information (name, date of birth, and gender), date of screening received, and outcome (e.g.,
included in the study, not included in the study, and their reasons). The screening items in
this phase are all part of the routine clinical treatment process, and the results of the
tests performed before the patient signs the informed consent form can be used for
evaluation. Patients who subsequently meet all inclusion and exclusion criteria are required
to sign the informed consent form before they can be enrolled in the trial.
Patients with hepatocellular carcinoma who meet the inclusion criteria are fully evaluated
during the screening phase to see if they meet the enrollment criteria.
Complete the following items within 28 days prior to treatment initiation.
- Obtain a written signed ICF.
- Demographic information: including date of birth, gender, ethnicity/race.
- History of alcohol consumption, history of smoking.
- Past medical and treatment history: take all past medical and treatment histories other
than this indication that began prior to signing the ICF and that are considered
relevant to this study.
- Physical examination: including head, eyes, ears, nose, throat, neck, heart, chest
(including lungs), abdomen, extremities, skin, lymph nodes, nervous system, and general
condition of the subject.
- Height and weight measurements.
- Vital signs: temperature, respiration, blood pressure and heart rate.
- ECOG score: it is recommended that the ECOG evaluation be performed by the same
investigator throughout the study period, as detailed in Appendix 4.
- Child-Pugh score (Appendix 5).
- CNLC staging and Barcelona liver cancer staging.
- Virological testing: hepatitis B two-for-half [including hepatitis B virus surface
antibody (HBsAb), HBsAg, hepatitis B virus e antigen (HBeAg), hepatitis B virus e
antibody (HBeAb), and HBcAb], HCV antibody, and HIV antibody.
- Review of inclusion and exclusion criteria to assess the eligibility of subjects for
inclusion.
- AE collection: for AEs after signing the ICF and before the first dose, they should be
recorded on the past medical history page of the CRF.
Complete the following items within 14 days prior to treatment initiation.
- Routine blood tests including: red blood cell count, hemoglobin, red blood cell
pressure, white blood cell count and classification (neutrophils, lymphocytes,
eosinophils, monocytes, basophils), and platelet count; obtain baseline values within 14
days prior to enrollment.
- Blood biochemical tests including: total protein, albumin, creatinine, ALP, lactate
dehydrogenase, total bilirubin, direct bilirubin, AST, ALT, calcium, phosphorus,
potassium, sodium, and chloride.
- Routine urine examination including: specific gravity, pH, urine sugar, protein,
tubular, ketone bodies, blood cells; 24-hour urine protein quantification is required if
2 consecutive urine protein tests are ++ or more or if the physician judges the results
to be abnormal and clinically significant.
- Fecal occult blood
- Coagulation tests including: aPTT, PT, TT, INR
- Blood pregnancy test: female subjects of childbearing age only.
- 12-lead electrocardiogram (ECG).
- alpha-fetoprotein (AFP).
- HBV-DNA quantification: HBV-infected subjects only.
- Tumor assessment: screening tumor assessment must be performed within 14 days prior to
enrollment and should include a CT or MRI scan of the chest, abdomen, or pelvis; if
clinically indicated, any other known or suspected disease site may be examined using
appropriate methods, such as a cranial MRI, bone scan, or CT scan of the neck; imaging
of tumors done for routine visits before the subject signs up for ICF need not be
repeated if done within 3 weeks prior to enrollment and at this study center; baseline
and follow-up assessments should be performed using the same imaging methods and
assessed by the same investigator whenever possible.
- Combined medication/combined treatment collection: all medication received by the
subject from 14 days prior to enrollment must be recorded in the CRF, including the
generic name and daily dose of the medication, the reason for the use of that
medication, the start date and the end date.
- Assign enrollment number.
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