HCC, Hepatic Arterial Infusion Chemotherapy, Regorafenib, Transarterial Chemoembolization
Conditions
Brief summary
explore the effectiveness and safety of conventional transarterial chemoembolization (cTACE) or transarterial chemoembolization (DEB-TACE) plus hepatic arterial Infusion chemotherapy (HAIC) combined with regorafenib and anti-PD-1 antibody or not for unresected hepatocellular carcinoma (uHCC)
Detailed description
This is a non-randomized, open, single-arm clinical study. Patients receive cTACE/DEB-TACE+HAIC treatment( 6-8 weeks as a cycle) and regorafenib and anti-PD1 antibody or not 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.
Interventions
DRUGRegorafenib
patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not
DEVICEcTACE/DEB-TACE-HAIC
conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion
Sponsors
Peking University Cancer Hospital & Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Volunteer to participate and sign the informed consent in writing; 2. Age: 18-75 years old; 3. No gender limit; 4. Unresectable hepatocellular carcinoma with clear pathological diagnosis or clinical diagnosis; 5. Unresectable hepatocellular carcinoma patients who failed first-line treatment (including but not limited to sorafenib, lenvatinib, atezolizumab combined with bevacizumab, etc.); 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. General physical condition (ECOG) 0-2; 10. Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dL, white blood cells ≥3.0×10\^9/L, neutrophils ≥1.5x 10\^9/L, platelets ≥80x 10\^9/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.
Exclusion criteria
1. Those who are currently receiving other effective treatments; 2. Patients who have received regorafenib 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate, ORR | 6 months | The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate |
| Progression free overall survival，PFS | 12 months | PFS was defined as the interval between the time at which treatment was initiated and intrahepatic tumor and/or extrahepatic tumor progression, symptomatic progression, including massive ascites and liver function that was categorized as Child-Pugh grade C, or death from any cause |
| Overall survival，OS | 24 months | overall survival (OS) was defined as the interval between the time at which treatment was initiated and death or the last follow-up assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate, DCR | 6 months | disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate |
Outcome results
None listed