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Active Not Recruiting NCT05621499

HAIC or Lenvatinib Combined With Sintilimab for High Recurrence Risk Resectable Solitary Hepatocellular Carcinoma

Conditions: Hepatocellular Carcinoma

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Tianjin Medical University Cancer Institute and Hospital

Location: Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality

Summary

To evaluate the safety and efficacy of HAIC or Lenvatinib combined with Sintilimab as a neoadjuvant therapy for high recurrence risk resectable stage IB solitary hepatocellular carcinoma

Eligibility Criteria

Inclusion Criteria: * Volunteer to join the study and signed the informed consent form * Aged 18-75, male or female * ECOG PS score 0-1 * Child Pugh liver function Grade A * Histopathology confirmed primary hepatocellular carcinoma (HCC) and the lesion met the indications for surgical resection in the Diagnostic and Therapeutic Norms for Primary Liver Cancer (2022) * According to the investigator's assessment, there are the following high recurrence risk factors, Stage Ⅰ b: solitary tumor, with the largest diameter \> 5cm * At least one measurable lesion according to RECIST 1.1 (measurable lesion CT/MRI scan length diameter ≥ 10mm or lymph node lesion CT/MRI scan short diameter ≥ 15mm, and measurable lesion has not received radiotherapy, cryotherapy and other local treatments) * Expected life ≥ 6 months * Functions of important organs shall meet the following requirements (excluding the use of any blood component and cell growth factor within 14 days) Neutrophils ≥ 1500/mm3Platelet count ≥ 60,000/mm3Hemoglobin ≥ 5.6 mmol/L (9 g/dL); Serum creatinine (SCR) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); The level of AST or ALT ≤ 2.5 times the upper limit of normal value (ULN); Urine protein\10mg/day prednisone or other equivalent therapeutic hormones) and continue to use them within 2 weeks before enrollment * Ascites or pleural effusion with clinical symptoms and requiring therapeutic puncture or drainage * There are clinical symptoms or diseases of the heart that are not well controlled, such as: 1. Heart failure above NYHA level 2 2. Unstable angina pectoris 3. Myocardial infarction occurred within 1 year 4. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention * Patients having gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding from tumors that have not been removed, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator at present (within 3 months) * Serious bleeding (\>30 ml bleeding within 3 months), hemoptysis (\>5 ml fresh blood within 4 weeks) or thromboembolism (including stroke and/or transient ischemic attack) occurred in the past or present * Patients with active infection or fever of unknown origin\>38.5℃during the screening period and before the first administration (according to the judgment of the investigator, subjects with fever due to tumor can be included) * Patients with past or current objective evidence of pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of pulmonary function * Patients with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria: HBV DNA ≥ 10e4/ml; HCV RNA ≥ 10e3/ml); Chronic hepatitis B virus carriers with HBV DNA\

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05621499). StuddyBuddy aggregates publicly available trial information.