Advanced Hepatocellular Carcinoma
Conditions
Keywords
RWS, Advanced Liver Cancer, PD-1
Brief summary
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;
Interventions
OTHERcamrelizumab
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
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Safety as defined by the NCI CTCAE v5.0 | From patients participate in the clinical study to 90 days after the end of treatment | Adverse events as graded by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 5 years | 1-year, 3-year, 5-year survival |
Countries
China
Contacts
Primary ContactXu-Feng Zhang, MD,phD
Backup ContactRui Qu
Outcome results
None listed