PD-1 Antibody and Lenvatinib Plus TACE on Downstaging BCLC B/C HCC

  • STATUS
    Recruiting
  • days left to enroll
    27
  • participants needed
    50
  • sponsor
    Fudan University
Updated on 4 October 2022
TACE

Summary

The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.

Details
Condition Adenocarcinoma, HEPATIC NEOPLASM, liver cell carcinoma, Malignant Adenoma, Liver Cancer, HEPATOCELLULAR CARCINOMA
Treatment PD-1 and Lenvatinib Plus TACE
Clinical Study IdentifierNCT04974281
SponsorFudan University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years old and 75 years old
Clinically diagnosed as hepatocellular carcinoma, stage B/C of BCLC
No history of severe arrhythmia or heart failure
No history of severe ventilation dysfunction or severe pulmonary infection
No acute or chronic renal failure, the creatinine clearance rate was >40 mL/min
Liver function Child A
Blood routine: absolute neutrophils count 1.510^9/L, Hb8.5g/L, PLT7510^9/L
Coagulation function: INR2.3
ECOG score <2
No local or systemic treatment, such as TACE, RFA, targeted drugs, traditional Chinese medicine, etc., before enrollment
Expected survival 12 weeks
At least one lesion can be measured and evaluated by CT/MRI according to RECIST 1.1 criteria
Understand and sign the informed consent

Exclusion Criteria

Pregnant or lactating women
Patients with other malignant tumors
patients with complicated mental illness
patients who have participated in other clinical trials in the last three months
known or suspected allergy to any drug related to the study
Patients with positive immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
Patients treated with other targeted drugs, PD-L1 antibody and other immunotherapy or FOLFOX systemic chemotherapy after inclusion
Patients with 1 + proteinuria indicated by urine routine will receive 24-hour urine protein detection, and patients with 1g 24-hour urine protein will not be included in the group
Active autoimmune diseases that require systemic treatment (use of disease-alleviating agents, such as corticosteroids or immunosuppressants)
Patients with uncontrolled hepatitis B/C infection
Other conditions that the researcher considers not suitable for inclusion in this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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