Advanced Hepatocellular Carcinoma (HCC)Phase 3NCT04985136
A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)
A Phase 3 study testing camrelizumab；Rivoceranib, Rivoceranib and Sorafenib in people with Advanced Hepatocellular Carcinoma (HCC), run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of Camrelizumab Combined with Rivoceranib Mesylate versus Investigator's Choice of Regimen in Treatment of Patients with Hepatocellular Carcinoma (HCC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC)
- What is being tested?
- camrelizumab；Rivoceranib, Rivoceranib and Sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2021to 29 Dec 2021
- Phase
- Phase 3
- 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
- Subject must participate voluntarily and sign the informed consent form;
- Aged ≥ 18 years old, male or female;
- Histopathologically confirmed hepatocellular carcinoma;
- Has PD on treatment with prior anti-PD-1/PD-L1/CTLA-4 monoclonal antibody (mAb) administered either as monotherapy or as combination therapy.
- No more than 2 lines of previous system treatment;
- Be able to provide fresh or archived tumor tissue samples;
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- Patient with at least one measurable lesion (for Stage I);
- Barcelona clinic liver cancer: Stage B or C;
- Child-Pugh score: ≤ 7;
- ECOG PS score of 0-1;
- Life expectancy of ≥ 12 weeks;
- Adequate organ function
- Must take one medically approved contraceptive measure
Who cannot join
- Patients with any active, known or suspected autoimmune disorder;
- Patients who have used corticosteroids or other immunosuppressive agents for systemic treatment within 1 month prior to randomization;
- With known severe allergic reactions to any other monoclonal antibodies;
- Received previous camrelizumab or rivoceranib mesylate treatment;
- Patients who discontinued ICIs treatment due to immune-related toxicity;
- Patients with known CNS metastasis or hepatic encephalopathy;
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- Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;;
- Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before randomization;
- Patients with other malignancies currently or within the past 5 years;
- Patients with hypertension which cannot be well controlled by antihypertensives; history of hypertensive crisis or hypertensive encephalopathy;
- Uncontrolled cardiac diseases or symptoms；
- Known hereditary or acquired bleeding disorders;
- Clinically significant bleeding symptoms or clear bleeding tendency;
- Patients with gastrointestinal perforation or gastrointestinal fistula;
- Patients with significant vascular invasions with a high possibility of fatal bleeding;
- Patients with important arterial/venous thrombosis;
- Patients experiencing toxicity caused by previous anti-tumor therapy that has not recovered to Grade ≤ 1;
- Patients with active infection;
- Patients with congenital or acquired immune deficiency;
- Patients who received live vaccines within 28 days prior to randomization, or are expect to be vaccinated during the treatment period;
- Patients with other potential factors that may affect the study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Controlled, International Multi-Center Phase III Clinical Study of Camrelizumab Combined With Rivoceranib (Apatinib) Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Hepatocellular Carcinoma (HCC) Who Have Been Treated With Immune Checkpoint Inhibitors (ICIs)
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of Camrelizumab Combined with Rivoceranib Mesylate versus Investigator's Choice of Regimen in Treatment of Patients with Hepatocellular Carcinoma (HCC)
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Being tested
- camrelizumab；Rivoceranib, Rivoceranib, Sorafenib, Regorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumab；RivoceranibDrug
Camrelizumab at 200 mg via intravenous administration (IV), once every 2 weeks (Q2W), in combination with 250 mg of rivoceranib mesylate, oral administration, once a day (QD)
RivoceranibDrug
Rivoceranib mesylate (750 mg, QD, po)
SorafenibDrug
Sorafenib tosylate (400 mg, twice a day (BID), po)
RegorafenibDrug
Regorafenib (160 mg, administer for 21 days then stop for 7 days, po)
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab + Rivoceranib | Experimental | Not described Receives: Drug: camrelizumab；Rivoceranib |
| Rivoceranib | Active comparator | Not described Receives: Drug: Rivoceranib |
| Sorafenib | Active comparator | Not described Receives: Drug: Sorafenib |
| Regorafenib | Active comparator | Not described Receives: Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage I：Objective Response Rate（ORR）
Measured: 2.5 years
Stage II：Overall survival （OS）
Measured: 2.5 years
Secondary outcomes (11)
Stage I：Overall survival （OS）
Measured: 2.5 years
Adverse Events（AEs）
Measured: 2.5 years
Stage II：Objective Response Rate（ORR）
Measured: 2.5 years
Disease Control Rate（DCR）
Measured: 2.5 years
Duration of Response（DoR）
Measured: 2.5 years
Progression-Free-Survival （PFS）
Measured: 2.5 years
time to progression （TTP）
Measured: 2.5 years
Pharmacokinetics (PK) Ctrough of camrelizumab
Measured: 2.5 years
Pharmacokinetics (PK) Ctrough of Apatinib
Measured: 2.5 years
Proportion of anti- camrelizumab antibody (ADA)
Measured: 2.5 years
Proportion of neutralizing antibody (Nab)
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start26 Sep 2021
- Primary completion29 Dec 2021
- Study completion29 Dec 2021
Why it stopped: Sponsor R \& D Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Parallel groups
- Model description
- Randomized，Open，Controlled, International Multi-Center
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT04985136
- Sponsor's protocol ID
- SHR-1210-III-330
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Controlled, International Multi-Center Phase III Clinical Study of Camrelizumab Combined With Rivoceranib (Apatinib) Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Hepatocellular Carcinoma (HCC) Who Have Been Treated With Immune Checkpoint Inhibitors (ICIs)
- ClinicalTrials.gov ID
- NCT04985136
- Acronym / sponsor ID
- SHR-1210-III-330
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor R \& D Strategy Adjustment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 2 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.
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of Camrelizumab Combined with Rivoceranib Mesylate versus Investigator's Choice of Regimen in Treatment of Patients with Hepatocellular Carcinoma (HCC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized，Open，Controlled, International Multi-Center
| Arm | Type | Receives |
|---|---|---|
| camrelizumab + Rivoceranib | Experimental | Drug: camrelizumab；Rivoceranib |
| Rivoceranib | Active comparator | Drug: Rivoceranib |
| Sorafenib | Active comparator | Drug: Sorafenib |
| Regorafenib | Active comparator | Drug: Regorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject must participate voluntarily and sign the informed consent form;
- Aged ≥ 18 years old, male or female;
- Histopathologically confirmed hepatocellular carcinoma;
- Has PD on treatment with prior anti-PD-1/PD-L1/CTLA-4 monoclonal antibody (mAb) administered either as monotherapy or as combination therapy.
- No more than 2 lines of previous system treatment;
Key exclusion criteria (21 listed)
- Patients with any active, known or suspected autoimmune disorder;
- Patients who have used corticosteroids or other immunosuppressive agents for systemic treatment within 1 month prior to randomization;
- With known severe allergic reactions to any other monoclonal antibodies;
- Received previous camrelizumab or rivoceranib mesylate treatment;
- Patients who discontinued ICIs treatment due to immune-related toxicity;
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；RivoceranibCamrelizumab at 200 mg via intravenous administration (IV), once every 2 weeks (Q2W), in combination with 250 mg of rivoceranib mesylate, oral administration, once a day (QD) | Drug | camrelizumab + Rivoceranib |
| RivoceranibRivoceranib mesylate (750 mg, QD, po) | Drug | Rivoceranib |
| SorafenibSorafenib tosylate (400 mg, twice a day (BID), po) | Drug | Sorafenib |
| RegorafenibRegorafenib (160 mg, administer for 21 days then stop for 7 days, po) | Drug | Regorafenib |
Primary outcome
Stage I：Objective Response Rate（ORR）
Time frame: 2.5 years
Stage II：Overall survival （OS）
Time frame: 2.5 years
11 secondary outcomes
Stage I：Overall survival （OS）
Time frame: 2.5 years
Adverse Events（AEs）
Time frame: 2.5 years
Stage II：Objective Response Rate（ORR）
Time frame: 2.5 years
Disease Control Rate（DCR）
Time frame: 2.5 years
Duration of Response（DoR）
Time frame: 2.5 years
Progression-Free-Survival （PFS）
Time frame: 2.5 years
time to progression （TTP）
Time frame: 2.5 years
Pharmacokinetics (PK) Ctrough of camrelizumab
Time frame: 2.5 years
Pharmacokinetics (PK) Ctrough of Apatinib
Time frame: 2.5 years
Proportion of anti- camrelizumab antibody (ADA)
Time frame: 2.5 years
Proportion of neutralizing antibody (Nab)
Time frame: 2.5 years
Results and safety
The study was stopped early (reason given: Sponsor R \& D Strategy Adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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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 camrelizumab；Rivoceranib, Rivoceranib and Sorafenib in people with Advanced Hepatocellular Carcinoma (HCC), 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 13 inclusion and 21 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: stopped early, as of the sponsor's last update on 1 Sep 2022. 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?
The study was stopped early (reason given: Sponsor R \& D Strategy Adjustment). 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?
Stage I：Objective Response Rate（ORR） (time frame: 2.5 years). 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 1 Sep 2022.