Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT04597970 |
Other study ID # |
2020YJZ41 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
October 20, 2020 |
Est. completion date |
October 20, 2022 |
Study information
Verified date |
October 2020 |
Source |
Beijing Cancer Hospital |
Contact |
Xu Zhu |
Phone |
86-01088196059 |
Email |
drzhuxu[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Purpose:explore the effectiveness and safety of transarterial chemoembolization (TACE) plus
Hepatic Arterial Infusion Chemotherapy (HAIC) with oxaliplatin and raltitrexed for Barcelona
stage C hepatocellular carcinoma (HCC)
Description:
Thhis is a non-randomized, open, single-arm clinical study. patients receive cTACE+HAIC
(oxaliplatin, raltitrexed) treatment, 6-8 weeks as a cycle, until the disease progresses,
intolerable toxicity occurs, the patient is lost to follow-up or death, or situations other
judged by researchers which treatment should be stopped.
Number of patients: 66 patients End points:primary end points:safety 、objective response
rate,disease control rate,progression free overall survival,second end point :overall
survival Include criteria:
1. Volunteer to participate and sign the informed consent in writing;
2. Age: 18-75 years old;
3. No gender limit;
4. BCLC stage C hepatocellular carcinoma with pathological diagnosis or clinical diagnosis;
5. Barcelona stage C patients who failed first-line treatment (including but not limited to
sorafenib, levatinib, atelizumab combined with bevacizumab, etc.); they have not
received sorafenib in the past The patients treated by Sorafenib can receive sorafenib
treatment at the same time, and the patients who have received sorafenib treatment
progress can also receive regorafenib treatment.
6. At least one measurable lesion (according to mRECIST criteria) imaging diagnosis time ≤
21 days from selection;
7. Child-pugh grade A-B7 grade
8. The expected survival period is ≥3 months;
9. ECOG Performance Status (ECOG) 0-2;
10. Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dL, white
blood cells ≥3.0×109/L, neutrophils ≥1.5x109/L, platelets ≥80x109/L; liver and kidney
functions are normal (Within 14 days): TBIL≤1.5 times the upper limit of normal; ALT and
AST≤5 times the upper limit of normal; creatinine≤1.5 times the upper limit of normal;
INR<1.7 or prolonged PT<4s
Exclude criteria:
1. Those who are currently receiving other effective treatments;
2. Patients who have received oxaliplatin and raltitrexed in the past;
3. Patients who have participated in other clinical trials within 4 weeks before
enrollment;
4. Unable to cooperate with cTACE and HAIC treatment;
5. Patients with primary malignant tumors other than hepatocellular carcinoma at the same
time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
6. Clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV),
uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled
hypertension or a history of myocardial infarction within the past 1 year;
7. Neurological or mental abnormalities that affect cognitive ability, including central
nervous system transfer;
8. There were active serious clinical infections (>grade 2 NCI-CTCAE version 4.0),
including active tuberculosis within 14 days before enrollment;
9. Known or self-reported HIV infection;
10. Uncontrolled systemic diseases, such as poorly controlled diabetes;
11. Known to have hypersensitivity or allergic reactions to any component of the study drug;
12. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding
Treatment:patients receive cTACE+HAIC (oxaliplatin, raltitrexed) treatment, 6-8 weeks as
a cycle, until the disease progresses, intolerable toxicity occurs, the patient is lost
to follow-up or death, or situations other judged by researchers which treatment should
be stopped.