- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05025592
cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC
August 28, 2021 updated by: Zhu Xu, Peking University Cancer Hospital & Institute
Conventional Transarterial Chemoembolization (cTACE) or Transarterial Chemoembolization (DEB-TACE) +HAIC Combined With Regorafenib ± Anti-PD1 Antibody for Unresected Hepatocellular Carcinoma
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)
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
60
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not
Other Names:
conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate, ORR
Time Frame: 6 months
|
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
Time Frame: 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
|
12 months
|
Overall survival,OS
Time Frame: 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
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate, DCR
Time Frame: 6 months
|
disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 10, 2021
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
August 24, 2021
First Submitted That Met QC Criteria
August 24, 2021
First Posted (Actual)
August 27, 2021
Study Record Updates
Last Update Posted (Actual)
September 2, 2021
Last Update Submitted That Met QC Criteria
August 28, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2021KT83
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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