Status:
UNKNOWN
The Efficacy and Safety of TACE, Lenvatinib and Camrelizumab in the Treatment of BCLC Stage B/C Hepatocellular Carcinoma: a Single-arm, Single-center, Open-label Study
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is a single-center, single-arm, open-label prospective clinical trial. By recording the disease-free progression (PFS), overall survival (OS) and tumor treatment response of the included pa...
Detailed Description
At present, the treatment methods for advanced liver cancer mainly include local interventional therapy, targeted therapy and immunotherapy.This study focused on patients with primary HCC diagnosed cl...
Eligibility Criteria
Inclusion
- From 18 to 75 years old, there are no gender restrictions, and the pre-survival period exceeds 12 weeks;
- Primary liver cancer diagnosed by clinical and imaging studies, histology or cytology;
- Liver cancer patients with B/C stage according to BCLC staging;
- Have not used molecular targeted therapy drugs or immune checkpoint inhibitors in the past;
- The behavioral status score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1;
- The main organ functions are normal, and there is no serious blood, heart, lung, liver, kidney dysfunction and immune deficiency diseases. Laboratory examination meets the following requirements: a. Hemoglobin (HGB) ≥ 90g/L; b. Neutrophil count (ANC) ≥ 1.5×109/L; c. Platelet count (PLT) ≥ 100×109/L; d. ALT and AST≤2.5×ULN; liver metastasis, then ALT and AST≤5×ULN; e. total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); f. serum Cr≤1'ULN, Endogenous creatinine clearance rate\>50ml/min (Cockcroft-Gault formula); g. Urine routine is normal, or urine protein \<(++), or 24-hour urine protein \<1.0 g;
- The coagulation function is normal, without active bleeding and thrombosis: a. International standardized ratio INR≤1.5×ULN; b. Partial thromboplastin time APTT≤1.5×ULN; c. Prothrombin time PT≤1.5×ULN ；
- The subject voluntarily joined the study and signed an informed consent form.
Exclusion
- Suffer from active malignant tumors other than liver cancer within five years or at the same time. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in the group;
- Liver cancer tumor size ≥ 70% of liver parenchyma or extrahepatic metastasis;
- Pregnant or lactating women;
- Known allergy to carrelizumab, lenvatinib or pharmaceutical excipients;
- Go through other anti-tumor treatments, including surgical treatment, local treatment and systemic treatment within 4 weeks before enrollment;
- Have received organ or allogeneic bone marrow transplantation;
- Suffer from any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, thyroid ·Reduced function (can be included after hormone replacement therapy)); Immune suppressive drugs have been used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (ie not more than 10 mg/day prednisolone or equivalent drug physiology Doses of other corticosteroids);
- Vaccination of live attenuated vaccine within 4 weeks before the first administration or planned during the study period;
- Severe infections (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or unexplained fever \>38.5°C during the screening period/before the first administration;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- There is objective evidence showing that he has suffered from pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.;
- Suffering from hypertension who cannot fall to the normal range after 3 months of treatment with antihypertensive drugs (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg);
- Suffer from uncontrollable clinical symptoms or diseases of the heart, including but not limited to congestive heart failure (NYHA grade\> Ⅱ grade); unstable or severe angina pectoris; acute myocardial infarction within 6 months; clinically significant Patients with supraventricular or ventricular arrhythmia requiring clinical intervention; left ventricular ejection fraction (LVEF) \<50%; Patients with active bleeding due to various reasons or patients at risk of severe bleeding, including but not limited to severe bleeding (bleeding\> 30 ml within 3 months), hemoptysis (bleeding\> 5 ml within 4 weeks) and occurring within 12 months Thromboembolic events (including stroke events and/or transient ischemic attacks);
- Participated in other clinical trials or participated in any other drug clinical research within 4 weeks, or no more than 5 half-lives from the last study drug;
- Other situations deemed unsuitable by the researcher.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04909866
Start Date
January 1 2021
End Date
December 1 2022
Last Update
June 2 2021
Active Locations (1)
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1
Wuhan Union Hospital
Wuhan, Hubei, China, 430030