Hepatocellular Carcinoma (HCC)Phase 3NCT04639180
A Study to Evaluate Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
A Phase 3 study testing Camrelizumab and Rivoceranib (Apatinib) in people with Hepatocellular Carcinoma (HCC), run by Jiangsu HengRui Medicine Co., Ltd. at 6 sites in China.
Trial summary
A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Camrelizumab and Rivoceranib (Apatinib)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 687 participants
- Where
- 6 sitesChina
- Study dates
- 1 Apr 2021to 31 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
- Subjects with a histopathological diagnosis of HCC
- Subjects who have undergone a curative resection or ablation (radiofrequency ablation [RFA] or microwave ablation [MVA] only)
- No previous systematic treatment and locoregional therapy for HCC prior to randomization
- Absence of major macrovascular invasion
- No extrahepatic spread
- Full recovery from Curative resection or ablation within 4 weeks prior to randomization
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- High risk for HCC recurrence after resection or ablation
- For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
- Child-Pugh Class: Grade A
- ECOG-PS score: 0 or 1
- Subjects with HCV- RNA (+) must receive antiviral therapy
- Adequate organ function
Who cannot join
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously
- Evidence of residual lesion, recurrence, and metastasis at randomization;
- Moderate-to-severe ascites with clinical symptoms
- History of hepatic encephalopathy
- History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage
- Active or history of autoimmune disease
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- Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
- Cardiac clinical symptom or cardiovascular disease that is not well controlled
- Severe infection within 4 weeks prior to the start of study treatment
- HIV infection
- Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
- Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
- Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- Known genetic or acquired hemorrhage or thrombotic tendency
- Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- Serious non-healing or dehiscing wound
- Major Curative procedure within four weeks
- Factors to affect oral administration
- Previous or current presence of metastasis to central nervous system
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Guizhou Cancer Hospital
Guiyang, Guizhou
Guangxi Medical University Affiliated Tumor Hospital
Nanjin, Guangzhou
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
About this study
Official title: A Randomized, Open-Label, Multi-Center, Phase Ⅲ Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Camrelizumab, Rivoceranib (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
Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder
Rivoceranib (Apatinib)Drug
Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (Camrelizumab Plus Rivoceranib (Apatinib)) | Experimental | Drug: Camrelizumab; Drug: Rivoceranib (Apatinib) Receives: Drug: Camrelizumab; Drug: Rivoceranib (Apatinib) |
| Control group (Active surveillance) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC)
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
Measured: Randomization up to approximately 43 months
Secondary outcomes (4)
RFS Rate at 24 and 36 Months, as Assessed by the Investigator
Measured: Randomization up to 24 months and up to 36 months
Time to Recurrence (TTR) as determined by the investigator and by BIRC
TTR defined as the time from randomization to first documented occurrence of local, regional, or metastatic HCC
Measured: Randomization up to approximately 43 months
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause
Measured: Randomization up to approximately 43 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Measured: Baseline up to approximately 43 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Apr 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 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 Carcinoma (HCC)Studies 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
- Crossover
- Model description
- Camrelizumab Combined with Rivoceranib (Apatinib) Versus Active Surveillance
- Masking
- None (open label)
- Enrolment
- 687 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
- NCT04639180
- Sponsor's protocol ID
- SHR-1210-III-325
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2020
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multi-Center, Phase Ⅲ Clinical Study of Camrelizumab Plus Rivoceranib (Apatinib) as Adjuvant Therapy in Patients With Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation
- ClinicalTrials.gov ID
- NCT04639180
- Acronym / sponsor ID
- SHR-1210-III-325
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 687 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Nov 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.
A Trial to Evaluate the Efficacy and Safety of Camrelizumab Plus Rivoceranib (Apatinib) Versus Active Surveillance as Adjuvant Therapy in Patients with Hepatocellular Carcinoma (HCC) at High Risk of Recurrence After Curative Resection or Ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Camrelizumab Combined with Rivoceranib (Apatinib) Versus Active Surveillance
| Arm | Type | Receives |
|---|---|---|
| Treatment group (Camrelizumab Plus Rivoceranib (Apatinib)) | Experimental | Drug: Camrelizumab, Drug: Rivoceranib (Apatinib)Drug: Camrelizumab; Drug: Rivoceranib (Apatinib) |
| Control group (Active surveillance) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects with a histopathological diagnosis of HCC
- Subjects who have undergone a curative resection or ablation (radiofrequency ablation [RFA] or microwave ablation [MVA] only)
- No previous systematic treatment and locoregional therapy for HCC prior to randomization
- Absence of major macrovascular invasion
- No extrahepatic spread
Key exclusion criteria (19 listed)
- Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar HCC; other active malignant tumor except HCC within 5 years or simultaneously
- Evidence of residual lesion, recurrence, and metastasis at randomization;
- Moderate-to-severe ascites with clinical symptoms
- History of hepatic encephalopathy
- History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal haemorrhage
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 |
|---|---|---|
| CamrelizumabSubjects receive Camrelizumab intravenously, Dosage form: lyophilized powder | Drug | Treatment group (Camrelizumab Plus Rivoceranib (Apatinib)) |
| Rivoceranib (Apatinib)Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet | Drug | Treatment group (Camrelizumab Plus Rivoceranib (Apatinib)) |
Primary outcome
Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC)
Time frame: Randomization up to approximately 43 months
RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by BIRC, or death from any cause (whichever occurs first).
4 secondary outcomes
RFS Rate at 24 and 36 Months, as Assessed by the Investigator
Time frame: Randomization up to 24 months and up to 36 months
Time to Recurrence (TTR) as determined by the investigator and by BIRC
Time frame: Randomization up to approximately 43 months
Overall Survival (OS)
Time frame: Randomization up to approximately 43 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Time frame: Baseline up to approximately 43 months
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 30 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Camrelizumab and Rivoceranib (Apatinib) in people with Hepatocellular Carcinoma (HCC), run by Jiangsu HengRui Medicine Co., Ltd. at 6 sites 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 12 inclusion and 19 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 30 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 6 sites 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?
Recurrence-Free Survival (RFS), as Determined by the blinded independent review committee (BIRC) (time frame: Randomization up to approximately 43 months). 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 30 Dec 2025.