Sintilimab Combined With Lenvatinib Versus HAIC for Perioperative Treatment of Resectable Primary Hepatocellular Carcinoma

  • End date
    Sep 1, 2025
  • participants needed
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 7 October 2022


This is a prospective, Two-arm, randomized,phase II clinical study of Sintilimab Combined With Lenvatinib Versus HAIC for perioperative treatment of resectable primary hepatocellular carcinoma with a high risk of recurrence.

Condition Resectable Hepatocellular Carcinoma
Treatment Sintilimab and Lenvatinib, HAIC-FOLFOX
Clinical Study IdentifierNCT05519410
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Patients volunteered to participate in this study and signed informed consent
Age 18-75, male or female
ECOG PS score 0-1
Child-pugh liver function grading: Grade A
The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to the indications for resectable operation in the Guidelines for diagnosis and Treatment of HCC (2019) edition
According to the preoperative evaluation of the researcher, the patient had a high risk of recurrence and met at least one of the risk factors
b: 2-3 tumors with the maximum diameter ≤3cm; IIa: tumor 2-3,biggest > 3 cm in diameter
According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI
scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node
lesions, and the lesion has not received radiotherapy, freezing or other local
Expected survival ≥ 6 months
The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days)
Blood routine
Neutrophils ≥1.5×109//L Platelet count ≥100×109/L Hemoglobin ≥90g/L
Liver and kidney function: Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value
(ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL)≤
5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 2.5 times the upper
limit of normal value (ULN); Urine protein <2+;If urinary protein ≥2+,24-hour quantitative
urine protein must be ≤1g
Normal coagulation function, no active bleeding and thrombotic disease A
International standardized ratio INR≤1.5×ULN; B. Partial thromboplastin time
APTT≤1.5×ULN; C. Prothrombin time PT≤1.5ULN
Women of childbearing age should agree to use contraceptives (such as intrauterine
devices, contraceptives or condoms) during and within six months of the end of
medication; Patients with negative serum or urine pregnancy tests within 7 days prior
to study inclusion and who must be non-lactating, and males should agree to use
contraceptives during the study period and for 6 months after the end of the study
Subjects have good compliance and cooperate with the follow-up

Exclusion Criteria

Have received radiotherapy, chemotherapy, concurrent chemoradiotherapy or other
targeted therapies before
Known hepatobiliary cell carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell
carcinoma and fibre-lamellar cell carcinoma; Active malignancies other than HCC within
years or concurrently
Having hypertension that cannot be well controlled by antihypertensive drug therapy
(systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);Previous
history of hypertension crisis or hypertensive encephalopathy
Subject has previous or concurrent malignancies (except cured basal cell carcinoma of
skin and carcinoma in situ of the cervix)
Previous treatment with Tislelizumab or other PD-1/PD-L1 treatment could not be
enrolled; Subjects are known to have prior allergies to macromolecular protein
reparations or to any Tislelizumab or Lenvatinib excipients
Subject has any active autoimmune disease or history of autoimmune disease (such as
but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis
hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism
hypothyroidism; Subjects with vitiligo or childhood asthma have been completely
relieved and may be included as adults without any intervention; Asthma requiring
medical intervention with bronchodilators will not be included)
Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone
therapy for immunosuppression purposes (>10mg/ day prednisone or other therapeutic
hormones) and continue to receive such therapy within 2 weeks prior to enrollment
Ascites or pleural effusion with clinical symptoms require therapeutic puncture or
Clinical symptoms or diseases of the heart that are not well controlled, such as
NYHA2 or above heart failure Unstable angina pectoris Myocardial infarction occurred within
Patients with clinically significant supraventricular or ventricular arrhythmia
requiring treatment or intervention
The patient currently (within 3 months) has gastrointestinal diseases such as
esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal
hypertension, or active bleeding in unresected tumors, or other conditions determined
by the researchers that may cause gastrointestinal bleeding or perforation
Past or present severe bleeding (>30 ml bleeding within 3 months), hemoptysis (>5 ml
fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or
tia) within 12 months
Subject has active infection or unexplained fever of >38.5 degrees during screening
and before first administration (subject's fever due to tumor can be enrolled
according to the investigator's judgment)
Patients with past or present objective evidence of pulmonary fibrosis, interstitial
pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia, severe
impairment of lung function, etc
Subjects with congenital or acquired immune deficiency, such as HIV infection, or
active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B
reference: HBV DNA≥1000/ml; Hepatitis C reference: HCV RNA≥103/ml);Chronic hepatitis B
virus carriers, HBV DNA < 1000 IU/ml, must receive antiviral treatment at the same
time during the test can be enrolled
Live vaccine is administered less than 4 weeks before or possibly during the study
The subject has a known history of psychotropic substance abuse, alcohol abuse or drug
The subject cannot or does not agree to bear the cost of the self-funded portion of
the examination and treatment, except for the clinical study drug, combined
chemotherapy and SAE related to the clinical study drug combined chemotherapy
Researchers think that should be left out in this study, the researchers determine
for example, the subjects have other factors that may result in this study were forced
to midway termination, such as, other serious disease (including mental illness) need
to merge treatment, there are serious abnormal laboratory examination, accompanied by
factors such as family or society, will affect the safety of the subjects, or
information and the collection of the sample
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