A Study of Sintilimab Combined With Apatinib and Capecitabine in Advanced Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • participants needed
    46
  • sponsor
    Xin-Hua Xu
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Updated on 16 February 2024
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cancer
ct scan
measurable disease
neutrophil count
MRI
vaccination
carcinoma
capecitabine
systemic chemotherapy
hepatitis
thyroid stimulating hormone
pd-1 inhibitor
apatinib
hepatocellular carcinoma
liver cancer
sintilimab
blood component

Summary

This study aims to evaluate the efficacy and safety of Sintilimab (an Anti-PD-1 Inhibitor) combined with apatinib and capecitabine as first-line therapy in patients with advanced hepatocellular carcinoma.

Details
Condition Adenocarcinoma, Adenocarcinoma, HEPATIC NEOPLASM, liver cancer, HEPATOCELLULAR CARCINOMA, liver cancer
Age 18years - 75years
Treatment Sintilimab Combined With Apatinib and Capecitabine
Clinical Study IdentifierNCT04411706
SponsorXin-Hua Xu
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patient has given written informed consent
Age between 18-75 years old.male or female
Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC(hepatocellular carcinoma) and with at least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1 standard
Subjects haven't received any systemic treatment that includes target-therapy, immunotherapy or chemotherapy for HCC before admission
liver function status Child-Pugh Class A; Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Expected survival 12 weeks
The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period)
Absolute neutrophil count1.5109 /L
Platelets80109/L ;Hemoglobin9.0 g/dL; Serum albumin3g/dL
Total bilirubin (TBIL)1.5upper limit of normal (ULN); ALT and AST1.5upper limit of normal(ULN); AKP 2.5upper limit of normal(ULN)
Thyroid stimulating hormone (TSH)1.0upper limit of normal(ULN)If abnormal, T3 and T4 levels should be examined at the same time
Serum creatinine 1.5ULN or creatinine clearance > 50 mL/minute (using Cockcroft-Gault formula)

Exclusion Criteria

Patients must not have had prior treatment with Sintilimab or any other PD-L1 or PD-1 antagonists
Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed
Known history of hypersensitivity to any components of the Sintilimab formulation, or other antibody formulation
Active central nervous system (CNS) metastases with clinical symptoms (including cerebral edema, steroid requirement, or progressive disease)
Patients with other malignant tumor (except cured skin basal cell carcinoma and cervical carcinoma)
Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class > 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) < 50%
Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg
Coagulation abnormalities (PT>16sAPTT>43sTT>21sFbg<2g/L), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy. Patients with or previous with serious hemorrhage (bleeding > 30 ml within 3 months), haemoptysis (> 5 ml within 4 weeks) of thromboembolic events within 12 months (including stroke events and/or transient ischemic attack)
Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency, such as: esophageal varices, local active ulcerative lesions, gastric ulcer and duodenal ulcer, the ulcerous colitis, gastrointestinal diseases such as portal hypertension or resection of tumor with bleeding risk, etc
Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc
History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis (transaminase does not meet the inclusion, hepatitis B virus (HBV) DNA 10 /ml or hepatitis C virus (HCV) RNA103 /ml or higher)
Participated in other clinical trials, or finish other clinical trials within 4 weeks. Patients who may receive other anti-tumor systemic chemotherapy during the study
Patients who may receive vaccination during the study, or previous had vaccination within 4 weeks
Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results
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