cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC

HCC Clinical Trial

Official title:

Conventional Transarterial Chemoembolization (cTACE) or Transarterial Chemoembolization (DEB-TACE) +HAIC Combined With Regorafenib ± Anti-PD1 Antibody for Unresected Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05025592
• Other study ID #: 2021KT83
• Status: Not yet recruiting
• Start date: September 10, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-chorionic gonadotropin test) or breast-feeding

Related Conditions & MeSH terms

• HCC
• Transarterial Chemoembolization

Intervention

Drug:
• Regorafenib
patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not

Device:
• cTACE/DEB-TACE-HAIC
conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate, ORR	The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate	6 months
Primary	Progression free overall survival,PFS	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	12 months
Primary	Overall survival,OS	overall survival (OS) was defined as the interval between the time at which treatment was initiated and death or the last follow-up assessment	24 months
Secondary	Disease control rate, DCR	disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate	6 months