Hepatocellular CarcinomaPhase 3NCT05320692
A Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) in Patients With Incurable Hepatocellular Carcinoma
A Phase 3 study testing TACE+Camrelizumab+Apatinib mesylate and TACE in people with Hepatocellular Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
A study to evaluate efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Rivoceranib (Apatinib) therapy in patients with incurable hepatocellular carcinoma. 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?
- TACE+Camrelizumab+Apatinib mesylate and TACE
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2022to 30 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Voluntarily participate in this study and sign informed consent.
- Subjects diagnosed with HCC or clinically diagnosed with HCC by histopathology / cytology.
- Baseline imaging examination has at least one measurable lesion.
- Child-Pugh liver function rating was Grade A Within 7 days before randomization.
- ECOG PS score within 7 days before randomization: 0 or 1. Other protocol defined inclusion criteria could apply.
Who cannot join
- Known hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and lamellar cell carcinoma.
- Subjects who are ready for or have previously received organ or allogeneic bone marrow transplantation.
- Has any active autoimmune disease or a history of autoimmune disease and may relapse.
- Suffering from hypertension and can not be well controlled by antihypertensive drugs.
- With clinical symptoms or diseases of the heart that are not well controlled.
- Previous or current central nervous system metastasis.
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- The subject has congenital or acquired immune deficiency (such as HIV infection).
- Thrombotic or embolic events occurred within 6 months prior to the start of study treatment.
- A history of gastrointestinal hemorrhage or a clear tendency to gastrointestinal bleeding within 6 months prior to the start of study treatment.
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to the start of study treatment.
- Severe, unhealed or cracked wounds and active ulcers or untreated fractures.
- Known genetic or acquired bleeding or thrombotic tendencies.
- Severe infection occurred within 4 weeks prior to the start of study treatment.
- Received live attenuated vaccine treatment within 28 days prior to the start of study treatment.
- Other investigational drugs were received within 28 days prior to the start of study treatment.
- According to the assessment of investigator, the subject has other factors that may interfere with the results of the study or cause the forced termination of the study. Other protocol defined exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Phase III, Randomized, Open-Label, Multi-center Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) or TACE Alone in Patients With Incurable Hepatocellular Carcinoma
A study to evaluate efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Rivoceranib (Apatinib) therapy in patients with incurable hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE+Camrelizumab+Apatinib mesylate, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE+Camrelizumab+Apatinib mesylateDrug
TACE. Camrelizumab，200mg，iv，once every 3 weeks. Apatinib mesylate, 250 mg, administered orally once daily，once every 3 weeks.
TACEProcedure or surgery
TACE Alone.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib). Receives: Drug: TACE+Camrelizumab+Apatinib mesylate |
| Control group | Active comparator | TACE Alone. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS assessed by BIRC
PFS is defined as the time from the date of randomization until the date of first objective disease progression or death (whichever occurs first).
Measured: approximately 5 years
Secondary outcomes (5)
OS
OS is defined as the time from the date of randomization until death due to any cause.
Measured: approximately 5 years
ORR
ORR is defined as the percentage of participants in the analysis population who have a CR or PR.
Measured: approximately 5 years
DCR
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD.
Measured: approximately 5 years
DoR
DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Measured: approximately 5 years
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Measured: approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start9 Aug 2022
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Randomized, Open-Label, Multi-center phase III clinical trial。
- Masking
- None (open label)
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320692
- Sponsor's protocol ID
- SHR-1210-Ⅲ-336
- Status last verified
- Dec 2025
- First submitted
- 2 Apr 2022
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-Label, Multi-center Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) or TACE Alone in Patients With Incurable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05320692
- Acronym / sponsor ID
- SHR-1210-Ⅲ-336
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 11 Apr 2022 (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.
A study to evaluate efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Rivoceranib (Apatinib) therapy in patients with incurable hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Randomized, Open-Label, Multi-center phase III clinical trial。
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: TACE+Camrelizumab+Apatinib mesylateTACE Combined With Camrelizumab Plus Rivoceranib (Apatinib). |
| Control group | Active comparator | Procedure: TACETACE Alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily participate in this study and sign informed consent.
- Subjects diagnosed with HCC or clinically diagnosed with HCC by histopathology / cytology.
- Baseline imaging examination has at least one measurable lesion.
- Child-Pugh liver function rating was Grade A Within 7 days before randomization.
- ECOG PS score within 7 days before randomization: 0 or 1. Other protocol defined inclusion criteria could apply.
Key exclusion criteria (16 listed)
- Known hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and lamellar cell carcinoma.
- Subjects who are ready for or have previously received organ or allogeneic bone marrow transplantation.
- Has any active autoimmune disease or a history of autoimmune disease and may relapse.
- Suffering from hypertension and can not be well controlled by antihypertensive drugs.
- With clinical symptoms or diseases of the heart that are not well controlled.
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 |
|---|---|---|
| TACE+Camrelizumab+Apatinib mesylateTACE. Camrelizumab，200mg，iv，once every 3 weeks. Apatinib mesylate, 250 mg, administered orally once daily，once every 3 weeks. | Drug | Treatment group |
| TACETACE Alone. | Procedure or surgery | Control group |
Primary outcome
PFS assessed by BIRC
Time frame: approximately 5 years
PFS is defined as the time from the date of randomization until the date of first objective disease progression or death (whichever occurs first).
5 secondary outcomes
OS
Time frame: approximately 5 years
ORR
Time frame: approximately 5 years
DCR
Time frame: approximately 5 years
DoR
Time frame: approximately 5 years
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TACE+Camrelizumab+Apatinib mesylate and TACE in people with Hepatocellular Carcinoma, run by Jiangsu HengRui Medicine Co., Ltd. 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 5 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
PFS assessed by BIRC (time frame: approximately 5 years). 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 11 Dec 2025.