Hepatocellular CarcinomaNCT04559607
TACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma
A study testing Camrelizumab, TACE and Apatinib in people with Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Camrelizumab, TACE and Apatinib
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2020to 31 Jan 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology
- -≥18 years
- China liver cancer staging: Ib-IIIa
- Child-Pugh score ≤6 point
- Previous TACE treatment(≤2 times) is permitted
- Adequate organ and marrow function
Who cannot join
- Participants who had another previous or current malignant tumor, except for early-stage cancer with low risk of recurrence or a malignant tumor curatively treated >5 years prior to enrolment with no recurrence
- Participants who have severe allergy to iodine, and unable to receive TACE
- Participants who have undergone a liver transplant or allogeneic bone marrow transplantation, or those who are in the waiting list for liver or bone marrow transplantation
- Participants who had congenital or acquired immune deficiency, such as HIV infection
- Participants who had a history of gastrointestinal bleeding within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding
- Participants who had undergone arterial thromboembolism within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding, such as cerebrovascular accident, ≥ CTCAE grade 3 deep vein thrombosis and pulmonary embolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TACE Combined With Camrelizumab and Apatinib Versus TACE in Intermediate and Advanced Hepatocelluar Carcinoma: a Randomized, Open-label, Multi-center Clinical Trials
The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC.
Read the detailed description
This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses is that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Camrelizumab, TACE, Apatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Camrelizumab: 200mg, iv, Q3W
TACEDevice
TACE if necessary
ApatinibDrug
Apatinib: 250m, po, QD
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: TACE+Camrelizumab+Apatinib | Experimental | Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE Receives: Drug: Camrelizumab; Device: TACE; Drug: Apatinib |
| Control group: TACE | Active comparator | TACE Receives: Device: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) by investigator
PFS is defined as the time from randomization to progression or death from any cause. Progression in this trial was determined as untreatable (UnTACEable) progression, defined as the inability of a patients to further receive or benefit from TACE for reasons. Progression in this trial also included progression that met the JSH criteria for TACE failure/refractoriness.
Measured: Up to ~2 years
Secondary outcomes (3)
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: Up to ~4 years
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Measured: Up to ~2 years
Time to untreatable (unTACEable) progression (TTUP) by investigator
TTUP is defined as the time from randomization to Child-Pugh grade C, intrahepatic tumor progression (>50% increase vs baseline), MVI or EHS (diameter>10 mm), and met the JSH criteria for TACE failure/refractoriness.
Measured: Up to ~2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start11 Sep 2020
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, Doctor, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559607
- Sponsor's protocol ID
- MA-HCC-II-005
- Status last verified
- Dec 2023
- First submitted
- 9 Sep 2020
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu HD, Fan WJ, Zhao C, Wang S, Li YL, Jin ZC, Zhang ZW, Guo JH, Cheng HT, Zhang Q, Lu J, Zeng YY, Lv WF, Xu H, Shao HB, Xu WG, Zhao XY, Gu SZ, Lin HL, Zheng WH, Piao LZ, Song YS, Zhao JB, Wang YC, Hou ZG, Sun Y, Guan N, Huang M, Yang WZ, Ji JS, Teng GJ. Transarterial Chemoembolization Combined With Camrelizumab and Rivoceranib for Unresectable Hepatocellular Carcinoma (CHANCE2005/CARES-005): A Randomized Phase II Trial. J Clin Oncol. 2026 Apr 10;44(11):959-969. doi: 10.1200/JCO-25-01796. Epub 2026 Feb 24.
PubMed 41734362
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACE Combined With Camrelizumab and Apatinib Versus TACE in Intermediate and Advanced Hepatocelluar Carcinoma: a Randomized, Open-label, Multi-center Clinical Trials
- ClinicalTrials.gov ID
- NCT04559607
- Acronym / sponsor ID
- MA-HCC-II-005
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 23 Sep 2020 (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.
The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC.
Detailed description
This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses is that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: TACE+Camrelizumab+Apatinib | Experimental | Drug: Camrelizumab, Device: TACE, Drug: ApatinibCamrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE |
| Control group: TACE | Active comparator | Device: TACETACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology
- -≥18 years
- China liver cancer staging: Ib-IIIa
- Child-Pugh score ≤6 point
- Previous TACE treatment(≤2 times) is permitted
Key exclusion criteria (6 listed)
- Participants who had another previous or current malignant tumor, except for early-stage cancer with low risk of recurrence or a malignant tumor curatively treated >5 years prior to enrolment with no recurrence
- Participants who have severe allergy to iodine, and unable to receive TACE
- Participants who have undergone a liver transplant or allogeneic bone marrow transplantation, or those who are in the waiting list for liver or bone marrow transplantation
- Participants who had congenital or acquired immune deficiency, such as HIV infection
- Participants who had a history of gastrointestinal bleeding within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding
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 |
|---|---|---|
| CamrelizumabCamrelizumab: 200mg, iv, Q3W | Drug | Experimental group: TACE+Camrelizumab+Apatinib |
| TACETACE if necessary | Device | Control group: TACE, Experimental group: TACE+Camrelizumab+Apatinib |
| ApatinibApatinib: 250m, po, QD | Drug | Experimental group: TACE+Camrelizumab+Apatinib |
Primary outcome
Progression-free survival (PFS) by investigator
Time frame: Up to ~2 years
PFS is defined as the time from randomization to progression or death from any cause. Progression in this trial was determined as untreatable (UnTACEable) progression, defined as the inability of a patients to further receive or benefit from TACE for reasons. Progression in this trial also included progression that met the JSH criteria for TACE failure/refractoriness.
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to ~4 years
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time frame: Up to ~2 years
Time to untreatable (unTACEable) progression (TTUP) by investigator
Time frame: Up to ~2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 41734362Zhu HD, Fan WJ, Zhao C, Wang S, Li YL, Jin ZC, Zhang ZW, Guo JH, Cheng HT, Zhang Q, Lu J, Zeng YY, Lv WF, Xu H, Shao HB, Xu WG, Zhao XY, Gu SZ, Lin HL, Zheng WH, Piao LZ, Song YS, Zhao JB, Wang YC, Hou ZG, Sun Y, Guan N, Huang M, Yang WZ, Ji JS, Teng GJ. Transarterial Chemoembolization Combined With Camrelizumab and Rivoceranib for Unresectable Hepatocellular Carcinoma (CHANCE2005/CARES-005): A Randomized Phase II Trial. J Clin Oncol. 2026 Apr 10;44(11):959-969. doi: 10.1200/JCO-25-01796. Epub 2026 Feb 24.
- Individual participant dataSharing planned: No
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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.
Gao-Jun Teng, Doctor principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camrelizumab, TACE and Apatinib in people with Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
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 6 inclusion and 6 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Progression-free survival (PFS) by investigator (time frame: Up to ~2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559607, which also lists 1 linked publication.
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 18 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.