Hepatocellular CarcinomaPhase 2NCT04826406
A Study of Camrelizumab Combined Apatinib in Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors (ICIs).
A Phase 2 study testing Camrelizumab combined Apatinib regimen in people with Hepatocellular Carcinoma and Immune Checkpoint Inhibitors, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to observe and preliminary explore the efficacy and safety of the combination of Camrelizumab and Apatinib regimen in treating advanced hepatocellular carcinoma (HCC) participants who have progressed following prior Immune Checkpoint Inhibitors (ICIs) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Immune Checkpoint Inhibitors
- What is being tested?
- Camrelizumab combined Apatinib regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 3 Feb 2021to 30 Aug 2023
- Phase
- Phase 2
- 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
- Aged 18 years old, both genders.
- Conform to the clinical diagnosis histological or cytological confirmation of HCC(hepatocellular carcinoma) and with at least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1.
- Liver function status Child-Pugh score less than or equal to 7.
- Barcelona Clinic Liver Cancer stage Category B or C.
- Disease progression following prior Immune Checkpoint Inhibitors (PD-1/PD-L1 or CTLA4 inhibitors) treatment for HCC, for at least 2 consecutive treatment cycles. Receipt of no more than 2 prior systemic therapies for advanced HCC.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate bone marrow, liver and renal function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment).
Who cannot join
- Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
- The prior ICIs treatments were discontinued by intolerable adverse events.
- Known or occurrence of central nervous system (CNS) metastases or hepatic encephalopathy.
- Patients with tumor burden ≥50% of the liver volume or received liver transplantation.
- Patients with clinical symptoms of ascites.
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.
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- Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class > 2), ventricular arrhythmia which need medical intervention.
- previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency, such as: esophageal varices, local active ulcerative lesions, gastric ulcer and duodenal ulcer, the ulcerous colitis, gastrointestinal diseases such as portal hypertension or resection of tumor with bleeding risk, etc.
- Proteinuria ≥ (++) and 24 hours total urine protein > 1.0 g.
- Prior systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, surgery or target therapy within 4 weeks (or 5 half-life of the drug, calculate the longer ) before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
- Prior Camrelizumab or Apatinib treatments.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Shaozhi Gu, MD, gushanzhi@hnca.org.cn
Shaozhi Gu, MD
About this study
Official title: Camrelizumab Combined Apatinib in Patients With Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors: A Single-Arm, Open-Label, Phase II Study.
The purpose of this study is to observe and preliminary explore the efficacy and safety of the combination of Camrelizumab and Apatinib regimen in treating advanced hepatocellular carcinoma (HCC) participants who have progressed following prior Immune Checkpoint Inhibitors (ICIs) treatment.
- Being tested
- Camrelizumab combined Apatinib regimen
- 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 Apatinib regimenDrug
Camrelizumab 200mg iv every 2 weeks; Apatinib,250 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+Apatinib | Experimental | Not described Receives: Drug: Camrelizumab combined Apatinib regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 12 months
Secondary outcomes (9)
Progression-free survival(PFS)
Progression-free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 12 months
Time to objective response(TTR)
Time to objective response(TTR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Measured: Up to approximately 12 months
Duration of Response (DoR)
Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 12 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Measured: Up to approximately 12 months
6-month survival rate
6-month survival rate
Measured: Up to approximately 12 months
9-month survival rate
9-month survival rate
Measured: Up to approximately 12 months
12-month survival rate
12-month survival rate
Measured: Up to approximately 12 months
Overall survival(OS)
Measured: Up to approximately 24 months
Safety as measured by the rate of AEs, SAEs and laboratory abnormalities
Safety as measured by the rate of AEs, SAEs and laboratory abnormalities (e.g. Grade 3 or higher per CTCAE v4 )
Measured: From the first assignment of informed consent form up to 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start3 Feb 2021
- Primary completion2 Mar 2022 (estimated)
- Study completion30 Aug 2023 (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.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826406
- Sponsor's protocol ID
- SHR-1210-IIT-HCC
- Status last verified
- Mar 2021
- First submitted
- 29 Mar 2021
- Last updated
- 1 Apr 2021
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined Apatinib in Patients With Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors: A Single-Arm, Open-Label, Phase II Study.
- ClinicalTrials.gov ID
- NCT04826406
- Acronym / sponsor ID
- SHR-1210-IIT-HCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 2 Mar 2022 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 1 Apr 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.
The purpose of this study is to observe and preliminary explore the efficacy and safety of the combination of Camrelizumab and Apatinib regimen in treating advanced hepatocellular carcinoma (HCC) participants who have progressed following prior Immune Checkpoint Inhibitors (ICIs) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+Apatinib | Experimental | Drug: Camrelizumab combined Apatinib regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years old, both genders.
- Conform to the clinical diagnosis histological or cytological confirmation of HCC(hepatocellular carcinoma) and with at least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1.
- Liver function status Child-Pugh score less than or equal to 7.
- Barcelona Clinic Liver Cancer stage Category B or C.
- Disease progression following prior Immune Checkpoint Inhibitors (PD-1/PD-L1 or CTLA4 inhibitors) treatment for HCC, for at least 2 consecutive treatment cycles. Receipt of no more than 2 prior systemic therapies for advanced HCC.
Key exclusion criteria (11 listed)
- Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
- The prior ICIs treatments were discontinued by intolerable adverse events.
- Known or occurrence of central nervous system (CNS) metastases or hepatic encephalopathy.
- Patients with tumor burden ≥50% of the liver volume or received liver transplantation.
- Patients with clinical symptoms of ascites.
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 Apatinib regimenCamrelizumab 200mg iv every 2 weeks; Apatinib,250 mg/day. | Drug | Camrelizumab+Apatinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 12 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
9 secondary outcomes
Progression-free survival(PFS)
Time frame: Up to approximately 12 months
Time to objective response(TTR)
Time frame: Up to approximately 12 months
Duration of Response (DoR)
Time frame: Up to approximately 12 months
Disease Control Rate (DCR)
Time frame: Up to approximately 12 months
6-month survival rate
Time frame: Up to approximately 12 months
9-month survival rate
Time frame: Up to approximately 12 months
12-month survival rate
Time frame: Up to approximately 12 months
Overall survival(OS)
Time frame: Up to approximately 24 months
Safety as measured by the rate of AEs, SAEs and laboratory abnormalities
Time frame: From the first assignment of informed consent form up to 90 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab combined Apatinib regimen in people with Hepatocellular Carcinoma and Immune Checkpoint Inhibitors, run by Hunan Cancer 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 8 inclusion and 11 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 1 Apr 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Shanzhi Gu, MD (+86-731-88651900, gushanzhi@hnca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 12 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 1 Apr 2021.