Potentially Resectable Hepatocellular CarcinomaPhase 2/3NCT06796803
Camrelizumab Combined With Rivoceranib and Hepatic Arterial Infusion Chemotherapy (HAIC) as Conversion Therapy for Potentially Resectable Hepatocellular Carcinoma(HCC)
A Phase 2/3 study testing camrelizumab combined with rivoceranib and HAIC and camerlizumab + rivoceranib in people with Potentially Resectable Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 2 sites in China.
Trial summary
The purpose of this phase 2/3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Potentially Resectable Hepatocellular Carcinoma
- What is being tested?
- camrelizumab combined with rivoceranib and HAIC and camerlizumab + rivoceranib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 2 sitesChina
- Study dates
- 20 Feb 2025to 28 Feb 2030
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form (ICF)
- Aged ≥18 years and ≤75 years at time of signing ICF
- Documented diagnosis of HCC confirmed by histology/cytology or clinically
- Patients with BCLC stage B (the sum of number of tumors and the maximum diameter of the largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepatic metastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumors in one lobe are present alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving the contralateral liver lobe or reaching the superior mesenteric vein. And no tumor thrombus of the inferior vena cava reaching right atrium
- Patients with recurrence following prior radical surgical resection must have undergone the initial surgery at least 5 years prior to study entry
- At least one measurable lesion (per RECIST v1.1) untreated lesion
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- ECOG performance status of 0 or 1
- Child-Pugh ≤7 score
- Life expectancy ≥12 weeks
- Adequate organ function
- No prior anti-tumor systemic therapies for HCC
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Other active malignant tumor except HCC within 5 years or simultaneously
- Prior locoregional therapy (such as TACE、TAE、HAIC、TARE)
- There is an absolute contraindication to HAIC
- History of hepatic encephalopathy
- Diffuse HCC, intrahepatic tumor burden > 50%
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- PVTT reaching the superior mesenteric vein, and bilateral PVTT are present
- Clinically significant ascites
- Prior allogeneic stem cell or solid organ transplantation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Sheng Tai, MD, PHD
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Camrelizumab and Rivoceranib Plus HAIC as Conversion Therapy for Potentially Resectable Intermediate-advanced Hepatocellular Carcinoma: a Multicenter, Open-label, Randomized, Phase 2/3 Study
The purpose of this phase 2/3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC.
Read the detailed description
This is a multicenter, open-label, randomized study designed to evaluate the efficacy and safety of camrelizumab combined with rivoceranib and HAIC as conversion therapy.
Eligible patients will be randomized into camrelizumab + rivoceranib + HAIC group and camrelizumab + rivoceranib group. Patients in camrelizumab + rivoceranib + HAIC group will receive systemic therapy and no more than 6 cycles HAIC procedure. Tumor response assessment using CT and/or MRI will be conducted according to RECIST v1.1. Those who are assessed as CR/PR or SD and considered suitable for curative hepatic resection will receive surgry. Surgical approaches will be tailored to the individual patient according to local standards with the goal of achieving R0 resection.The first administration of postoperative camrelizumab + rivoceranib treatment is recommended to start within 4-6 weeks after surgery, requiring full recovery from the surgery prior to post-operative camrelizumab + rivoceranib treatment. Patients in camrelizumab + rivoceranib group will receive the systemic therapy until progression or unacceptable toxicity.
- Being tested
- camrelizumab combined with rivoceranib and HAIC, camerlizumab + rivoceranib
- Keywords
- conversion therapy, hepatocellular carcinoma, camrelizumab and rivoceranib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumab combined with rivoceranib and HAICDrug
systemic therapy combined with locoregional theraphy as conversion therapy
camerlizumab + rivoceranibDrug
systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab + rivoceranib + HAIC | Experimental | Not described Receives: Drug: camrelizumab combined with rivoceranib and HAIC |
| camrelizumab + rivoceranib | Active comparator | Not described Receives: Drug: camerlizumab + rivoceranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 rate
R0 rate defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin
Measured: 24 months
dual primary endpoint: EFS and OS
Event-free survival (EFS), defined as the time from randomization to progression (RECIST v1.1), recurrence and death from any cause.
Overall survival (OS) after randomization, defined as the time from randomization to death from any cause
Measured: 36 months
Secondary outcomes (5)
ORR
Objective response rate (ORR), defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.
Measured: 24 months
DCR
Disease Control Rate (DCR), defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: 24 months
pCR rate
Pathological complete regression (pCR) rate, defined as the proportion of patients with no evidence of vital residual tumor cells on the complete resected specimen. pCR status will be analyzed by local pathologists at each site
Measured: 24 months
MPR rate
MPR rate, defined as the proportion of patients with evidence of vital residual tumor cells on the resected specimen. MPR status will be analyzed by local pathologists at each site
Measured: 24 months
AE
Adverse events are graded according to the NCI-CTCAE (Version 5.0)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start20 Feb 2025
- Primary completion20 Feb 2028 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Resectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796803
- Sponsor's protocol ID
- MA-HCC-II/III-026
- Other IDs
- 2024ZD0520401
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2025
- Last updated
- 17 Jul 2026
- 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 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab and Rivoceranib Plus HAIC as Conversion Therapy for Potentially Resectable Intermediate-advanced Hepatocellular Carcinoma: a Multicenter, Open-label, Randomized, Phase 2/3 Study
- ClinicalTrials.gov ID
- NCT06796803
- Acronym / sponsor ID
- MA-HCC-II/III-026
- Keywords
- conversion therapy, hepatocellular carcinoma, camrelizumab and rivoceranib
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Feb 2028 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 28 Jan 2025 (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 phase 2/3 study is to investigate the efficacy and safety of camrelizumab combined with rivoceranib and hepatic arterial infusion chemotherapy (HAIC) as conversion therapy for Potentially Resectable HCC.
Detailed description
This is a multicenter, open-label, randomized study designed to evaluate the efficacy and safety of camrelizumab combined with rivoceranib and HAIC as conversion therapy.
Eligible patients will be randomized into camrelizumab + rivoceranib + HAIC group and camrelizumab + rivoceranib group. Patients in camrelizumab + rivoceranib + HAIC group will receive systemic therapy and no more than 6 cycles HAIC procedure. Tumor response assessment using CT and/or MRI will be conducted according to RECIST v1.1. Those who are assessed as CR/PR or SD and considered suitable for curative hepatic resection will receive surgry. Surgical approaches will be tailored to the individual patient according to local standards with the goal of achieving R0 resection.The first administration of postoperative camrelizumab + rivoceranib treatment is recommended to start within 4-6 weeks after surgery, requiring full recovery from the surgery prior to post-operative camrelizumab + rivoceranib treatment. Patients in camrelizumab + rivoceranib group will receive the systemic therapy until progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| camrelizumab + rivoceranib + HAIC | Experimental | Drug: camrelizumab combined with rivoceranib and HAIC |
| camrelizumab + rivoceranib | Active comparator | Drug: camerlizumab + rivoceranib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed Informed Consent Form (ICF)
- Aged ≥18 years and ≤75 years at time of signing ICF
- Documented diagnosis of HCC confirmed by histology/cytology or clinically
- Patients with BCLC stage B (the sum of number of tumors and the maximum diameter of the largest tumor exceeding Up-to-7 criteria) and BCLC stage C without extrahepatic metastasis: ① tumors confined to one lobe (left, right, or middle lobe), or tumors in one lobe are present alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes; ②No PVTT involving the contralateral liver lobe or reaching the superior mesenteric vein. And no tumor thrombus of the inferior vena cava reaching right atrium
- Patients with recurrence following prior radical surgical resection must have undergone the initial surgery at least 5 years prior to study entry
Key exclusion criteria (9 listed)
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Other active malignant tumor except HCC within 5 years or simultaneously
- Prior locoregional therapy (such as TACE、TAE、HAIC、TARE)
- There is an absolute contraindication to HAIC
- History of hepatic encephalopathy
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 |
|---|---|---|
| camrelizumab combined with rivoceranib and HAICsystemic therapy combined with locoregional theraphy as conversion therapy | Drug | camrelizumab + rivoceranib + HAIC |
| camerlizumab + rivoceranibsystemic therapy | Drug | camrelizumab + rivoceranib |
Primary outcome
R0 rate
Time frame: 24 months
R0 rate defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin
dual primary endpoint: EFS and OS
Time frame: 36 months
Event-free survival (EFS), defined as the time from randomization to progression (RECIST v1.1), recurrence and death from any cause. Overall survival (OS) after randomization, defined as the time from randomization to death from any cause
5 secondary outcomes
ORR
Time frame: 24 months
DCR
Time frame: 24 months
pCR rate
Time frame: 24 months
MPR rate
Time frame: 24 months
AE
Time frame: 24 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 17 Jul 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing camrelizumab combined with rivoceranib and HAIC and camerlizumab + rivoceranib in people with Potentially Resectable Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 2 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 11 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Huichuan Sun, MD, PHD (sun.huichuan@zs-hospital.sh.cn, sun.huichuan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 rate (time frame: 24 months). The study lists 2 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 17 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.