Hepatocellular CarcinomaPhase 1NCT04564313
Safety and Efficacy of Camrelizumab (Anti-PD-1 Antibody) in Recurrent HCC After Liver Transplantation
A Phase 1 study testing Camrelizumab treatment in people with Hepatocellular Carcinoma and Liver Transplantation, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This is a prospective clinical study to investigate the safety and efficacy of anti-PD-1 immunotherapy (Camrelizumab) in patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation. All of the enrolled patients have a background of liver transplantation for HCC. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Transplantation
- What is being tested?
- Camrelizumab treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2020to Jul 2023
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old, male or female;
- Pathologically confirmed hepatocellular carcinoma after liver transplantation;
- Tumor recurrence or metastasis is confirmed by CT and/or MRI examination, and neither intrahepatic recurrence nor extrahepatic metastasis is suitable for surgical resection;
- At least one measurable recurrent or metastatic tumor lesion;
- Tumor progression (mRECIST) or intolerance to treatment was assessed at least 1 month after oral administration of sorafenib or lenvatinib;
- The expected survival time is more than 3 months;
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- Child-Pugh grade A or B (≤7 points);
- Other vital organs' function: The absolute count of neutrophils ≥1.5×10E9/L; Platelet ≥50×10E9/L; Hemoglobin ≥9g/dL; Serum albumin ≥2.8g/dL; Thyroid stimulating hormone (TSH) ≤1 times ULN (If TSH is abnormal, T3 and T4 levels should be examined at the same time. Then, if both T3 and T4 levels are normal, patient could be enrolled); Bilirubin ≤1.5 times ULN; ALT and AST ≤3 times ULN; Serum creatinine ≤1.5 times ULN;
- ECOG score 0-2 points;
- Patients have sufficient understanding and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment plan, laboratory examination and other requirements of the study schedule.
Who cannot join
- Positive PD-L1 expression in liver biopsy by immunohistochemistry (either liver parenchyma or non-parenchymal cells);
- Be Allergic to Camrelizumab;
- ≥ Grade II myocardial ischemia or myocardial infarction;
- With hypertension that can't be controlled to normal level with medication (SBP >140mmHg, DBP >90mmHg);
- With abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), and with a history of gastrointestinal bleeding within 6 months;
- With high risk of bleeding or is receiving thrombolysis or anticoagulant therapy;
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- With autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, psoriasis, etc;
- The primary liver disease for liver transplantation was autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis;
- With pulmonary diseases such as interstitial pneumonia and poor lung function;
- Participating in clinical trials of other experimental drugs within four weeks;
- With infections requiring systemic treatment;
- With positive infection of human immunodeficiency virus (HIV);
- Special groups that not recommended in the instructions of Camrelizumab: with moderate or severe insufficiency of liver and renal function;
- With MDM2/4 amplification, EGFR mutation, or JAK mutation by NGS sequencing;
- With other factors that may influence the safety or compliance;
- During the treatment of acute rejection or within 1 month after treatment;
- Poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510630
Wang Guoying, M.D., 086-13632407313, wanggy3@126.com
About this study
Official title: Clinical Study of Anti-PD-1 Antibody Camrelizumab in the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplantation
This is a prospective clinical study to investigate the safety and efficacy of anti-PD-1 immunotherapy (Camrelizumab) in patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation. All of the enrolled patients have a background of liver transplantation for HCC. Due to the tumor recurrence, patients are not suitable for curative surgical resection, and targeted therapy provides poor therapeutic effect, leading to tumor progression or intolerance. Before immunotherapy, the PD-L1 expression was confirmed negative in the graft liver by immunohistochemistry, and patients continued targeted therapy as part of a combined antitumor regimen. In addition, the immunosuppression schedule is also reduced to a low level.
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation
- Being tested
- Camrelizumab treatment
- 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 treatmentDrug
Camrelizumab (SHR-1210), 200mg, I.V., Q3W
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab treatment | Experimental | Camrelizumab (SHR-1210), 200mg, I.V., Q3W Receives: Drug: Camrelizumab treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate after Camrelizumab treatment according to the mRECIST
Measured: 2 years
Secondary outcomes (5)
Overall Survival (OS)
Time from the initiation of Camrelizumab treatment to the patient death from any cause
Measured: 2 years
Progression-free Survival (PFS)
Time from the initiation of Camrelizumab treatment to radiological tumor progression or death from any cause
Measured: 2 years
Time to Progression (TTP)
Time from the initiation of Camrelizumab treatment to radiological tumor progression
Measured: 2 years
Serious Adverse Event (SAE)
The incidence of serious adverse event caused by Camrelizumab treatment
Measured: 2 years
Graft Rejection (GR)
The incidence of graft rejection during the Camrelizumab treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start21 Sep 2020
- Primary completionSep 2022 (estimated)
- Study completionJul 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Guoying, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564313
- Sponsor's protocol ID
- [2020]-02-061-01
- Status last verified
- Apr 2022
- First submitted
- 21 Sep 2020
- Last updated
- 3 May 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 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Anti-PD-1 Antibody Camrelizumab in the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplantation
- ClinicalTrials.gov ID
- NCT04564313
- Acronym / sponsor ID
- [2020]-02-061-01
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 25 Sep 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.
This is a prospective clinical study to investigate the safety and efficacy of anti-PD-1 immunotherapy (Camrelizumab) in patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation. All of the enrolled patients have a background of liver transplantation for HCC. Due to the tumor recurrence, patients are not suitable for curative surgical resection, and targeted therapy provides poor therapeutic effect, leading to tumor progression or intolerance. Before immunotherapy, the PD-L1 expression was confirmed negative in the graft liver by immunohistochemistry, and patients continued targeted therapy as part of a combined antitumor regimen. In addition, the immunosuppression schedule is also reduced to a low level.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab treatment | Experimental | Drug: Camrelizumab treatmentCamrelizumab (SHR-1210), 200mg, I.V., Q3W |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-65 years old, male or female;
- Pathologically confirmed hepatocellular carcinoma after liver transplantation;
- Tumor recurrence or metastasis is confirmed by CT and/or MRI examination, and neither intrahepatic recurrence nor extrahepatic metastasis is suitable for surgical resection;
- At least one measurable recurrent or metastatic tumor lesion;
- Tumor progression (mRECIST) or intolerance to treatment was assessed at least 1 month after oral administration of sorafenib or lenvatinib;
Key exclusion criteria (17 listed)
- Positive PD-L1 expression in liver biopsy by immunohistochemistry (either liver parenchyma or non-parenchymal cells);
- Be Allergic to Camrelizumab;
- ≥ Grade II myocardial ischemia or myocardial infarction;
- With hypertension that can't be controlled to normal level with medication (SBP >140mmHg, DBP >90mmHg);
- With abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), and with a history of gastrointestinal bleeding within 6 months;
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 treatmentCamrelizumab (SHR-1210), 200mg, I.V., Q3W | Drug | Camrelizumab treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
Objective Response Rate after Camrelizumab treatment according to the mRECIST
5 secondary outcomes
Overall Survival (OS)
Time frame: 2 years
Progression-free Survival (PFS)
Time frame: 2 years
Time to Progression (TTP)
Time frame: 2 years
Serious Adverse Event (SAE)
Time frame: 2 years
Graft Rejection (GR)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Camrelizumab treatment in people with Hepatocellular Carcinoma and Liver Transplantation, run by Third Affiliated Hospital, Sun Yat-Sen 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 10 inclusion and 17 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 3 May 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 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.
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 Guoying Wang, M.D. (+86-13632407313, wanggy3@126.com), 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: 2 years). 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 3 May 2022.