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

NCT04909866 | Unknown Phase 2

• 1 other identifier: CXPJJH12000001-2020223
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 patients, it is planned to evaluate TACE, lenvatinib and carrelizumab in the treatment of BCLC B/C hepatocytes Survival benefits of cancer patients; at the same time, the immune indicators before and after treatment are tested, the dosage is optimized, and the mechanism of combination therapy in liver cancer is explored to lay the foundation for screening more suitable treatment populations; laboratory testing indicators and adverse events To observe and evaluate the safety of combined therapy; adopt immunohistochemistry, pathology, cell biology, proteomics and imagingomics methods to comprehensively evaluate the changes after combined therapy.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

  The period of time between the date of randomization until the date of first documented progression , assessed up to 24 months

Secondary Outcomes (1)

• OS

  From date of randomization until the date of death from any cause, assessed up to 24 months

Study Arms (1)

TACE+Lenvatinib+Camrelizumab

EXPERIMENTAL

Combination Product: TACE+Lenvatininb+Camrelizumab

Interventions

TACE+Lenvatininb+Camrelizumab COMBINATION_PRODUCT

Patients included in the trial were treated with TACE, lenvatinib combined with Camrelizumab.

TACE+Lenvatinib+Camrelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: June 2, 2021
• Study Start: January 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

CN (1)