HCCNCT05025592
cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC
An observational study of HCC and Transarterial Chemoembolization, run by Peking University Cancer Hospital & Institute.
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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC, Transarterial Chemoembolization, Hepatic Arterial Infusion Chemotherapy
- What is being tested?
- Regorafenib and cTACE/DEB-TACE-HAIC
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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
About this study
Official title: 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)
Read the 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.
- Being tested
- Regorafenib, cTACE/DEB-TACE-HAIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
Also called anti-PD1 antibody
patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not
cTACE/DEB-TACE-HAICDevice
Also called conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion
conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Regorafenib; Device: cTACE/DEB-TACE-HAIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate, ORR
The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate
Measured: 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
Measured: 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
Measured: 24 months
Secondary outcomes (1)
Disease control rate, DCR
disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start10 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Xu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025592
- Sponsor's protocol ID
- 2021KT83
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Transarterial Chemoembolization (cTACE) or Transarterial Chemoembolization (DEB-TACE) +HAIC Combined With Regorafenib ± Anti-PD1 Antibody for Unresected Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05025592
- Acronym / sponsor ID
- 2021KT83
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 10 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody | – | Drug: Regorafenib, Device: cTACE/DEB-TACE-HAICpatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.);
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegorafenibAlso: anti-PD1 antibodypatients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not | Drug | cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody |
| cTACE/DEB-TACE-HAICAlso: conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusionconventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion | Device | cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody |
Primary outcome
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
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
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
1 secondary outcome
Disease control rate, DCR
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC and Transarterial Chemoembolization, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate, ORR (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.