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

NCT05025592 | Unknown DMC FDA Drug FDA Device

• 1 other identifier: 2021KT83
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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)

Conditions

HCC; Transarterial Chemoembolization; Hepatic Arterial Infusion Chemotherapy; Regorafenib

Outcome Measures

Primary Outcomes (3)

• Objective response rate, ORR

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

  6 months

• 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

• 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 Outcomes (1)

• Disease control rate, DCR

  6 months

Study Arms (1)

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; Device: cTACE/DEB-TACE-HAIC

Interventions

Regorafenib DRUG

patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not

Also known as: anti-PD1 antibody

cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody

cTACE/DEB-TACE-HAIC DEVICE

conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion

Also known as: conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion

cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with unresectable hepatocellular carcinoma are fail for fisrt line treatment((including but not limited to sorafenib, levatinib, atelizumab combined with bevacizumab, etc.) and will received cTACE/DEB-TACE plus HAIC and regorafenib and anti-PD1 antibody or not.

You may qualify if:

• Volunteer to participate and sign the informed consent in writing;
• Age: 18-75 years old;
• No gender limit;
• Unresectable hepatocellular carcinoma with clear pathological diagnosis or clinical diagnosis;
• Unresectable hepatocellular carcinoma patients who failed first-line treatment (including but not limited to sorafenib, lenvatinib, atezolizumab combined with bevacizumab, etc.);
• At least one measurable lesion (according to mRECIST criteria) imaging diagnosis time ≤ 21 days from selection;
• Child-pugh grade A-B7 grade
• The expected survival period is ≥3 months;
• General physical condition (ECOG) 0-2;
• 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.

You may not qualify if:

• Those who are currently receiving other effective treatments;
• Patients who have received regorafenib in the past;
• Patients who have participated in other clinical trials within 4 weeks before enrollment;
• Unable to cooperate with cTACE and HAIC treatment;
• 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;
• 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;
• Neurological or mental abnormalities that affect cognitive ability, including central nervous system transfer;
• There were active serious clinical infections (\>grade 2 NCI-CTCAE version 4.0), including active tuberculosis within 14 days before enrollment;
• Known or self-reported HIV infection;
• Uncontrolled systemic diseases, such as poorly controlled diabetes;
• Known to have hypersensitivity or allergic reactions to any component of the study drug;
• Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Interventions

regorafenib; spartalizumab

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital Chief Physician，MD

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 27, 2021
• Study Start: September 10, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-08