Advanced Hepatocellular CarcinomaNCT04487704
Camrelizumab Utilization on Patients With Advanced Liver Cancer
A study testing camrelizumab in people with Advanced Hepatocellular Carcinoma, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2020to Jan 2025
- Phase
- Interventional
- 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
- 18 years old or more;
- For both men and women;
- Patients with advanced liver cancer confirmed by histopathology or cytology; .Volunteer to join the study, sign the informed consent, good compliance, and cooperate with the follow-up.
Who cannot join
- A known allergy to the study drug or any of its excipients; Or had a severe allergic reaction to other monoclonal antibodies;
- Patients who are ready for or have previously received an organ or allogeneic bone marrow transplant;
- Pregnant or lactating women;
- According to the judgment of the researcher, the patients should not be included in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Yi Lv, MD,PHD, 0086-13991200581, luyi169@126.com
Xiaogang Zhang, Phd, 0086-13891803523, zzsghr@qq.com
About this study
Official title: A Real World Study of Treatment Regimens Containing Camrelizumab in Patients With Advanced Liver Cancer
To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer
Read the detailed description
camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of circulating T lymphocytes, and binds to epitopes different from Nivolumab and pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for indication for advanced hepatocellular carcinoma The main objective of this study was to observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab in advanced liver cancer。 The subjects included people over 18 years old， For men and women with advanced liver cancer confirmed by histopathology or cytology;
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- camrelizumab
- Keywords
- RWS, Advanced Liver Cancer, PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumabOther
camrelizumab 200 mg, intravenous infusion (no need for prophylactic administration), no less than 30 min ，No more than 60 min, one cycle every 2 weeks (14 days) or one cycle every 3 weeks (21 days). Try to complete the administration before the ECG
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab in the treatment of liver cancer | Other | Camrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min Receives: Other: camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Safety as defined by the NCI CTCAE v5.0
Adverse events as graded by CTCAE v5.0
Measured: From patients participate in the clinical study to 90 days after the end of treatment
Secondary outcomes (1)
overall survival
1-year, 3-year, 5-year survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start7 Apr 2020
- Primary completion1 Jan 2023 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Lyu, MD,phD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487704
- Sponsor's protocol ID
- XJYFY-KRLZ-HCC-1
- Status last verified
- Apr 2022
- First submitted
- 27 May 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Treatment Regimens Containing Camrelizumab in Patients With Advanced Liver Cancer
- ClinicalTrials.gov ID
- NCT04487704
- Acronym / sponsor ID
- XJYFY-KRLZ-HCC-1
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- RWS, Advanced Liver Cancer, PD-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 27 Jul 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.
To observe and evaluate the safety and efficacy of camrelizumab in advanced liver cancer
Detailed description
camrelizumab ， a humanized monoclonal antibody against PD-1, has been shown to block the binding of PD-1 to PD-L1, thereby inhibiting the immune escape of tumor cells. It has a high affinity for PD-1 (KD = 3.31 nmol/L), a high acceptor proportion (85% at 200 mg) of circulating T lymphocytes, and binds to epitopes different from Nivolumab and pembrolizumab，Phase 1 clinical trials have shown that camrelizumab is well tolerated and has antitumor activity in patients with advanced solid tumors.camrelizumab has been approved for indication for advanced hepatocellular carcinoma The main objective of this study was to observe and evaluate the safety and efficacy of treatment regiments containing Camrelizumab in advanced liver cancer。 The subjects included people over 18 years old， For men and women with advanced liver cancer confirmed by histopathology or cytology;
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab in the treatment of liver cancer | Other | Other: camrelizumabCamrelizumab intravenous infusion (no need for prophylactic administration), no less than 30 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or more;
- For both men and women;
- Patients with advanced liver cancer confirmed by histopathology or cytology; .Volunteer to join the study, sign the informed consent, good compliance, and cooperate with the follow-up.
Key exclusion criteria (4 listed)
- A known allergy to the study drug or any of its excipients; Or had a severe allergic reaction to other monoclonal antibodies;
- Patients who are ready for or have previously received an organ or allogeneic bone marrow transplant;
- Pregnant or lactating women;
- According to the judgment of the researcher, the patients should not be included in this study
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 |
|---|---|---|
| camrelizumabcamrelizumab 200 mg, intravenous infusion (no need for prophylactic administration), no less than 30 min ，No more than 60 min, one cycle every 2 weeks (14 days) or one cycle every 3 weeks (21 days). Try to complete the administration before the ECG | Other | Camrelizumab in the treatment of liver cancer |
Primary outcome
Assess Safety as defined by the NCI CTCAE v5.0
Time frame: From patients participate in the clinical study to 90 days after the end of treatment
Adverse events as graded by CTCAE v5.0
1 secondary outcome
overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 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.
Yi Lyu, MD,phD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing camrelizumab in people with Advanced Hepatocellular Carcinoma, run by First Affiliated Hospital Xi'an Jiaotong 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 3 inclusion and 4 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 Apr 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.
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 Xu-Feng Zhang, MD,phD (86-029-13359260373, xfzhang125@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Safety as defined by the NCI CTCAE v5.0 (time frame: From patients participate in the clinical study to 90 days after the end of treatment). 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 Apr 2022.