Hepatocellular CarcinomaPhase 2NCT04523662
Study on the Effectiveness and Safety of Carrelizumab Combined With Apatinib Mesylate and Radiotherapy in the Treatment of Advanced Liver Cancer
A Phase 2 study testing Camrelizumab Apatinib Mesylas in people with Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
Literature has shown that radiotherapy can promote tumor antigen presentation, mobilize and activate T cells by enhancing activation signals and blocking inhibitory signals. It can also lead to the normalization of blood vessels in the tumor microenvironment and the increase of CXCL16 and other chemokines to activate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Camrelizumab Apatinib Mesylas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2020to 1 Aug 2022
- 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
- 1. Age: ≥18 years old, male or female; 2. Patients with hepatocellular carcinoma diagnosed by imaging examination or pathology; 3. Not suitable for surgical resection or local treatment, patients with lymph or lung metastasis; 4.Child-Pugh score: Grade A, normal liver volume (liver volume-gross tumor volume) > 700 ml; 5. The ECOG score is 0-1 within one week before entering the group; 6. There is at least one measurable lesion that meets the mRECIST and RECIST 1.1 standards; 7. The expected survival time is ≥3 months; 8. The main organs function normally, that is, they meet the following standards:
- routine blood examination: no blood transfusion, no G-CSF, no drug correction within 14 days before screening) Hb ≥90g/L, ANC ≥1.5×109/L, PLT ≥50×109/L, WBC ≥2.5×109/L ..
- creatinine ≤1.5ULN. 9. Patients with active hepatitis B virus (HBV) infection: HBV-DNA < 2000IU/ml (if the research center has only copy/mL detection unit, it must be < 104Copy/ml), and receive antiviral treatment before and during the treatment; Patients with hepatitis c virus (HCV) RNA positive: HCV-RNA < 103/ml, must receive antiviral treatment according to local standard treatment guidelines, and the liver function is increased within ctcae grade 1.
- 10. Women of childbearing age (generally 15-49 years old) must have a negative pregnancy test (serum or urine) within 14 days before entering the group, and voluntarily adopt appropriate methods of contraception during the observation period and within 8 weeks after the last administration of research drugs; For men, they should be sterilized by surgery or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of study drugs.
- 11. The subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.
Who cannot join
- Those with a history of esophageal and gastric variceal bleeding, hepatic encephalopathy, massive ascites and abdominal infection.
- Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation;
- Previously used immunosuppressive drugs within 14 days before the first use of Karelizumab, excluding nasal spray and inhaled corticosteroids or systemic steroid hormones with physiological dose (i.e. prednisolone or other corticosteroids with the same physiological dose);
- It is known to be allergic to apatinib, kareli zumab or pharmaceutical excipients; Or severe allergic reaction to other monoclonal antibodies;
- Vaccinate live attenuated vaccine within 4 weeks before the first administration or during the study period;
- There are peripheral neuropathy of grade > 1;
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- Any other malignant tumor that has been diagnosed, except basal cell or squamous cell skin cancer or cervical carcinoma in situ that has been fully treated;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);
- Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, NYHA 2 or above cardiac insufficiency, arrhythmia with poor control (including QTcF interval > 450 ms for men and > 470 ms for women, QTcF interval calculated by Fridericia formula), symptomatic congestive heart failure;
- Hypertension patients with uncontrollable drugs;
- Abnormal coagulation function (INR>1.5 or APTT>1.5×ULN), bleeding tendency or being treated with thrombolytic therapy, anticoagulant therapy or antiplatelet therapy, etc.;
- It is known that there are hereditary or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.;
- There is obvious cough blood within 2 months before entering the study, or the daily cough blood volume reaches half a teaspoon (2.5 ml) or more;
- Patients with gastrointestinal bleeding risk, including the following:
- Active peptic ulcer lesions; (2) Those who have a history of black stool and hematemesis within 3 months; (3) For fecal occult blood (+) or (+/-), it needs to be reviewed within 1 week, and gastroscopy should be performed if it is still (+) or (+/-). If there is ulcer or hemorrhagic disease, and the attending doctor thinks there is potential bleeding risk; 15. Arterial/venous thrombosis events occurred within 6 months before entering the study, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism, etc.; 16. Infections requiring drug intervention within 4 weeks before the first administration (such as intravenous drip of antibiotics, antifungal or antiviral drugs), or fever of unknown cause > 38.5°C； during screening/before the first administration; 17. Participated in any other drug clinical research within 4 weeks before the first administration; 18. It is known that there is a history of psychotropic drug abuse or drug abuse; 19. There are other serious physical or mental diseases or abnormal laboratory examination, which may increase the risk of participating in the study, or interfere with the results of the study, and the researchers think that the patients are not suitable for participating in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Effectiveness and Safety of Carrelizumab Combined With Apatinib Mesylate and Radiotherapy in the Treatment of Advanced Liver Cancer With Extrahepatic Metastasis
Literature has shown that radiotherapy can promote tumor antigen presentation, mobilize and activate T cells by enhancing activation signals and blocking inhibitory signals. It can also lead to the normalization of blood vessels in the tumor microenvironment and the increase of CXCL16 and other chemokines to activate T cells. The cells infiltrate the tumor tissues better and promote the killing activity of T cells. Therefore, the combined application of radiotherapy and immunotherapy may have a synergistic effect. Apatinib is a small molecule tyrosine protein kinase inhibitor for VEGFR. Low-dose apatinib can induce the normalization of abnormal blood vessels in tumors, effectively increase the infiltration of lymphocytes in tumor tissues, and block immunosuppressive myeloid cells. Recruitment, reverse the immunosuppressive state, effectively reduce the level of TGF-β, and make the tumor environment tend to have an immune support phenotype. Apatinib combined with PD-1 antibody karelizumab has been confirmed in a phase I study to have good efficacy and safety in patients with advanced liver cancer. Therefore, this study intends to use the PD-1 antibody carrelizumab combined with apatinib and radiotherapy to treat patients with advanced liver cancer with extrahepatic metastasis, to evaluate the effectiveness and safety of the combined therapy, and to provide new clinical treatments for liver cancer Evidence-based medicine.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Camrelizumab Apatinib Mesylas
- 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 Apatinib MesylasDrug
This study intends to use the PD-1 antibody carrelizumab combined with apatinib and radiotherapy to treat patients with advanced liver cancer with extrahepatic metastasis
| Study group | Role | What they receive |
|---|---|---|
| Carrelizumab treatment group started during radiotherapy | Experimental | Not described Receives: Drug: Camrelizumab Apatinib Mesylas |
| Start the carrelizumab treatment group within 3 days after the | Experimental | Not described Receives: Drug: Camrelizumab Apatinib Mesylas |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Time from treatment start to disease progression or death from any cause
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start30 Aug 2020 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (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 Beijing Tsinghua Chang Gung 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Gong, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523662
- Sponsor's protocol ID
- 20200805
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness and Safety of Carrelizumab Combined With Apatinib Mesylate and Radiotherapy in the Treatment of Advanced Liver Cancer With Extrahepatic Metastasis
- ClinicalTrials.gov ID
- NCT04523662
- Acronym / sponsor ID
- 20200805
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 30 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 21 Aug 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.
Literature has shown that radiotherapy can promote tumor antigen presentation, mobilize and activate T cells by enhancing activation signals and blocking inhibitory signals. It can also lead to the normalization of blood vessels in the tumor microenvironment and the increase of CXCL16 and other chemokines to activate T cells. The cells infiltrate the tumor tissues better and promote the killing activity of T cells. Therefore, the combined application of radiotherapy and immunotherapy may have a synergistic effect. Apatinib is a small molecule tyrosine protein kinase inhibitor for VEGFR. Low-dose apatinib can induce the normalization of abnormal blood vessels in tumors, effectively increase the infiltration of lymphocytes in tumor tissues, and block immunosuppressive myeloid cells. Recruitment, reverse the immunosuppressive state, effectively reduce the level of TGF-β, and make the tumor environment tend to have an immune support phenotype. Apatinib combined with PD-1 antibody karelizumab has been confirmed in a phase I study to have good efficacy and safety in patients with advanced liver cancer. Therefore, this study intends to use the PD-1 antibody carrelizumab combined with apatinib and radiotherapy to treat patients with advanced liver cancer with extrahepatic metastasis, to evaluate the effectiveness and safety of the combined therapy, and to provide new clinical treatments for liver cancer Evidence-based medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carrelizumab treatment group started during radiotherapy | Experimental | Drug: Camrelizumab Apatinib Mesylas |
| Start the carrelizumab treatment group within 3 days after the | Experimental | Drug: Camrelizumab Apatinib Mesylas |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Age: ≥18 years old, male or female; 2. Patients with hepatocellular carcinoma diagnosed by imaging examination or pathology; 3. Not suitable for surgical resection or local treatment, patients with lymph or lung metastasis; 4.Child-Pugh score: Grade A, normal liver volume (liver volume-gross tumor volume) > 700 ml; 5. The ECOG score is 0-1 within one week before entering the group; 6. There is at least one measurable lesion that meets the mRECIST and RECIST 1.1 standards; 7. The expected survival time is ≥3 months; 8. The main organs function normally, that is, they meet the following standards:
- routine blood examination: no blood transfusion, no G-CSF, no drug correction within 14 days before screening) Hb ≥90g/L, ANC ≥1.5×109/L, PLT ≥50×109/L, WBC ≥2.5×109/L ..
- creatinine ≤1.5ULN. 9. Patients with active hepatitis B virus (HBV) infection: HBV-DNA < 2000IU/ml (if the research center has only copy/mL detection unit, it must be < 104Copy/ml), and receive antiviral treatment before and during the treatment; Patients with hepatitis c virus (HCV) RNA positive: HCV-RNA < 103/ml, must receive antiviral treatment according to local standard treatment guidelines, and the liver function is increased within ctcae grade 1.
- 10. Women of childbearing age (generally 15-49 years old) must have a negative pregnancy test (serum or urine) within 14 days before entering the group, and voluntarily adopt appropriate methods of contraception during the observation period and within 8 weeks after the last administration of research drugs; For men, they should be sterilized by surgery or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of study drugs.
- 11. The subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.
Key exclusion criteria (15 listed)
- Those with a history of esophageal and gastric variceal bleeding, hepatic encephalopathy, massive ascites and abdominal infection.
- Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation;
- Previously used immunosuppressive drugs within 14 days before the first use of Karelizumab, excluding nasal spray and inhaled corticosteroids or systemic steroid hormones with physiological dose (i.e. prednisolone or other corticosteroids with the same physiological dose);
- It is known to be allergic to apatinib, kareli zumab or pharmaceutical excipients; Or severe allergic reaction to other monoclonal antibodies;
- Vaccinate live attenuated vaccine within 4 weeks before the first administration or during the study period;
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 Apatinib MesylasThis study intends to use the PD-1 antibody carrelizumab combined with apatinib and radiotherapy to treat patients with advanced liver cancer with extrahepatic metastasis | Drug | Carrelizumab treatment group started during radiotherapy, Start the carrelizumab treatment group within 3 days after the |
Primary outcome
PFS
Time frame: 24months
Time from treatment start to disease progression or death from any cause
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab Apatinib Mesylas in people with Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung Hospital.
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 5 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 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Gong Li, Master (13366061906, dr_gongli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 24months). 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 21 Aug 2020.