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

• Sponsor: Peking University Cancer Hospital & Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05025592
• Collaborator: (none)
• Enrollment: 60
• Anticipated Duration (Months): 15.7

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
HCC; Transarterial Chemoembolization; Hepatic Arterial Infusion Chemotherapy; Regorafenib	Drug: Regorafenib; Device: cTACE/DEB-TACE-HAIC

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Conventional Transarterial Chemoembolization (cTACE) or Transarterial Chemoembolization (DEB-TACE) +HAIC Combined With Regorafenib ± Anti-PD1 Antibody for Unresected Hepatocellular Carcinoma
• Anticipated Study Start Date: Sep 10, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm

Intervention/Treatment

cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody patients will receive the combination treatment of cTACE/DEB-TACE plus HAIC and combined with regorafenib and anti-PD1 antibody or not. The anti-PD-1 antibody will be used depended on the contraindications or wishes of patients.

Drug: Regorafenib; patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not; Other Names: anti-PD1 antibody ; Device: cTACE/DEB-TACE-HAIC; conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion; Other Names: conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion

Outcome Measures

Primary Outcome Measures

1. Objective response rate, ORR [6 months]

   The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate

2. 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

3. 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 Outcome Measures

1. Disease control rate, DCR [6 months]

   disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Peking University Cancer Hospital & Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhu Xu, Hospital Chief Physician，MD, Peking University Cancer Hospital & Institute
• ClinicalTrials.gov Identifier: NCT05025592
• Other Study ID Numbers: 2021KT83
• First Posted: Aug 27, 2021
• Last Update Posted: Sep 2, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Sep 2, 2021