Hepatocellular CarcinomaPhase 1/2NCT04035876
Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of HCC Before Liver Transplant
A Phase 1/2 study testing Camrelizumab plus apatinib in people with Hepatocellular Carcinoma and Liver Transplant, run by Zhejiang University at 1 site in China.
Trial summary
To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Transplant
- What is being tested?
- Camrelizumab plus apatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2019to 31 Dec 2021
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years
- Pathology: hepatocellular carcinoma
- Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor and AFP ≤ 100 ng/mL; Type B: diameter of tumor >8 cm, but 100 ng/mL < AFP <400 ng/mL)
- No interventional therapy (TACE, RFA or I131) within 2 month
- Expected survival for more than 3 months
- Child-pugh grade A or grade B (≤ 7 points)
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- Absolute neutrophil count ≥ 1.5×10^9 /L, Hb ≥ 9 g/L, PLT ≥ 100×10^9 /L; TSH ≤ ULN; total bilirubin ≤ 1.5 ULN, albumin ≥ 28 g/L, AST, ALT ≤ 3 ULN; serum creatinine ≤ 1.5 ULN
- ECOG: 0-2
- Patients participate in the study voluntarily and sign informed consent
Who cannot join
- Regional lymph node metastases or extrahepatic metastases
- Allergic to Camrelizumab or Apatinib
- Patients who have had or are currently complicated with other malignant tumors
- Active hepatitis (hepatitis B: HBsAg positive or HBV- DNA≥10⁴copies/ml; hepatitis C: HCV antibodies and HCV-RNA positive)
- Activ pulmonary tuberculosis or pulmonary tuberculosis history
- Active, diagnosed, or suspected autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma)
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- Interstitial lung disease history or non-infectious pneumonia requiring oral or intravenous steroid therapy
- Long-term systemic hormone therapy (dose > 10mg prednisone/day) or any other form of immunosuppressive therapy
- Myocardial ischemia or myocardial infarction above grade II, hypertension and inability to reach the normal range after medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)
- Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L); history of gastrointestinal bleeding within 6 months; obvious bleeding tendency or undergoing thrombolytic or anticoagulant treatment
- Pregnant or lactating women
- Patients who participated in other clinical trials within 1 month
- Active infections which require systemic treatment
- HIV positive
- Other factors that may affect patients' safety or compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, 310003
Jianguo Wang, PhD, (+86)15967123327
About this study
Official title: A Single Group, Open Label, Multi-center Clinical Study of Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of Hepatocellular Cancer Before Liver Transplant
To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
Read the detailed description
HCC patients waiting for liver transplantation will be screened and enrolled according to the inclusion criteria. After screening and enrollment, patients will be administrated camrelizumab 200mg q2w iv and apatinib 250mg qd po regimen every 4 weeks as a cycle. Each patient will receive camrelizumab treatment for at least 2 cycles and discontinue camrelizumab 5 weeks before liver transplantation. Apatinib will be discontinued 1 week before liver transplantation. Once the tumor progression was detected, the program will be terminated and the appropriate optimal treatment will be given. The objective remission rate (ORR), recurrence-free survival (RFS), overall survival (OS), time to progress (TTP) and any adverse effect during the study will be evaluated in order to assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
- Conditions
- Hepatocellular Carcinoma, Liver Transplant
- Being tested
- Camrelizumab plus apatinib
- Keywords
- Camrelizumab, Apatinib, HCC, Liver transplantation
- 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 plus apatinibDrug
Camrelizumab 200mg q2w iv and apatinib 250mg qd po.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab plus apatinib | Experimental | Not described Receives: Drug: Camrelizumab plus apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate
The proportion of patients with CR, PR, and SD in the group
Measured: From enrollment to disease progression, up to 6 months
Recurrence-free survival
The period from enrollment surgery to recurrence of HCC
Measured: 1 year
Secondary outcomes (3)
Overall survival
The survival rate in a year
Measured: 1 year
Time to progress
The period from enrollment to disease progression
Measured: From enrollment to disease progression, up to 6 months
Adverse effect
Any adverse effects occur during the project
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start16 Jul 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 Zhejiang UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital, West China Hospital, Huashan Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Tianjin First Central Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Xiao Xu, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035876
- Sponsor's protocol ID
- KY2019-SHR-APA-ZJU
- Status last verified
- Jul 2019
- First submitted
- 20 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group, Open Label, Multi-center Clinical Study of Combination Camrelizumab (SHR-1210) and Apatinib for Downstaging/Bridging of Hepatocellular Cancer Before Liver Transplant
- ClinicalTrials.gov ID
- NCT04035876
- Acronym / sponsor ID
- KY2019-SHR-APA-ZJU
- Conditions
- Hepatocellular Carcinoma, Liver Transplant
- Keywords
- Camrelizumab, Apatinib, HCC, Liver transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital, West China Hospital, Huashan Hospital, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Jilin University, Tianjin First Central Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 16 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Jul 2019 (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.
To assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
Detailed description
HCC patients waiting for liver transplantation will be screened and enrolled according to the inclusion criteria. After screening and enrollment, patients will be administrated camrelizumab 200mg q2w iv and apatinib 250mg qd po regimen every 4 weeks as a cycle. Each patient will receive camrelizumab treatment for at least 2 cycles and discontinue camrelizumab 5 weeks before liver transplantation. Apatinib will be discontinued 1 week before liver transplantation. Once the tumor progression was detected, the program will be terminated and the appropriate optimal treatment will be given. The objective remission rate (ORR), recurrence-free survival (RFS), overall survival (OS), time to progress (TTP) and any adverse effect during the study will be evaluated in order to assess the primary effects and safety of camrelizumab (SHR-1210) plus apatinib for downstaging/bridging of HCC before liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab plus apatinib | Experimental | Drug: Camrelizumab plus apatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-75 years
- Pathology: hepatocellular carcinoma
- Exceed Hangzhou Criteria (Type A: diameter of tumor ≤ 8 cm or diameter of tumor and AFP ≤ 100 ng/mL; Type B: diameter of tumor >8 cm, but 100 ng/mL < AFP <400 ng/mL)
- No interventional therapy (TACE, RFA or I131) within 2 month
- Expected survival for more than 3 months
Key exclusion criteria (15 listed)
- Regional lymph node metastases or extrahepatic metastases
- Allergic to Camrelizumab or Apatinib
- Patients who have had or are currently complicated with other malignant tumors
- Active hepatitis (hepatitis B: HBsAg positive or HBV- DNA≥10⁴copies/ml; hepatitis C: HCV antibodies and HCV-RNA positive)
- Activ pulmonary tuberculosis or pulmonary tuberculosis history
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 plus apatinibCamrelizumab 200mg q2w iv and apatinib 250mg qd po. | Drug | Camrelizumab plus apatinib |
Primary outcome
Objective remission rate
Time frame: From enrollment to disease progression, up to 6 months
The proportion of patients with CR, PR, and SD in the group
Recurrence-free survival
Time frame: 1 year
The period from enrollment surgery to recurrence of HCC
3 secondary outcomes
Overall survival
Time frame: 1 year
Time to progress
Time frame: From enrollment to disease progression, up to 6 months
Adverse effect
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: No
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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 1/2 study testing Camrelizumab plus apatinib in people with Hepatocellular Carcinoma and Liver Transplant, run by Zhejiang University 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 9 inclusion and 15 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 29 Jul 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jianguo Wang, PhD ((+86)15967123327, 21118059@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate (time frame: From enrollment to disease progression, up to 6 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 29 Jul 2019.