A Exploratory Study of Apatinib Adjuvant Therapy for Hepatocellular Carcinoma With Portal Vein Invasion Who Underwent Radical Resection
Apatinib
Carcinoma+8
+ Adenocarcinoma
+ Enfermedades del Sistema Digestivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 20 de julio de 2017
Fecha en la que se inscribió al primer participante.Portal vein tumor thrombus (PVTT) is one of the characteristics of advanced stage for patients with hepatocellular carcinoma (HCC). There's limited treatment choice for these patients. Even for those who underwent curative resection (R0 resection), the recurrence rate was extremely high. Apatinib is a highly selective VEGFR2 inhibitor and reduces the angiogenesis of tumor efficiently, which had been proven effective in many solid tumors, is a Chinese domestic TKI targeting vascular endothelial growth factor receptor. Phase 2 study of apatinib for patients with advanced HCC had shown signals of clinical efficacy and modest safety. In this study, we aim to evaluate the effects and safety of adjuvant apatinib therapy for the patients who underwent R0 resection for HCC with PVTT.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 70 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: 1. Aged from 18-70 years. 2. HCC diagnosis confirmed by pathological examination who did not receive anti-tumor treatment (anti-tumor treatment including but not limited to: local ablation therapy, TACE, radiation therapy, chemotherapy, targeted drug therapy, etc.) 3. Underwent radical resection for hepatocellular carcinoma with portal vein tumor thrombus, as assessed by preoperative imaging or intraoperative findings, within 4 weeks 4. Child-Pugh class: A or B7 5. The ECOG: 0-1 points 6. The expected survival time ≥ 6 months. 7. Main organs function is normal including: * blood routine examination * HB ≥ 90 g/L * ANC ≥ 1.5×109 /L * PLT ≥ 80×109/L * biochemical test * ALB ≥ 29 g/L * ALT\<3 ULN and AST\< 3 ULN * TBIL ≤ 1.5 ULN * Serum creatinine ≤ 1.5 ULN; 8. Women of childbearing age must have pregnancy tests (serum or urine) within 7 days prior to admission, and the results are negative and are willing to use appropriate methods of contraception at 8 weeks after the trial and at the end of the test. For men, surgical sterilization should be applied, or consent to the appropriate method of contraception 8 weeks after the trial and at the end of the trial; 9. subjects voluntarily joined the study, signed informed consent, good compliance, and followed up. Exclusion Criteria: 1. Hepatic duct carcinoma、mixed cell carcinoma and fiberboard layer cell carcinoma which have confirmed; Past (5 years) or current with other malignant tumor, except skin basal cell carcinoma and cervical carcinoma in situ. 2. Patients with hypertension who are unable to fall within normal range by antihypertensive medications (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg). 3. With the second level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc interval = 450 ms, male female = 470 ms). 4. Factors that affect oral medication, such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect the use and absorption of drugs. 5. Ascites with clinical symptoms requires therapeutic peritoneal paracentesis or drainage. 6. In the past 6 months, with the history of alimentary tract hemorrhage or definite gastrointestinal bleeding tendency, such as: the risk of bleeding esophageal varices, local active ulcerative lesions, fecal occult blood; For those with fecal occult blood (+), gastroscopy is required. 7. Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 28 days before entry; 8. Postoperative complications were not relieved. 9. Abnormal coagulation function (INR \> 1.5 or prothrombin time (PT) \> ULN+4 seconds), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy; 10. Past and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug associated pneumonia, and severe lung function impairment; 11. Urine routine showed that urinary protein is more than + + or confirmed 24 hours urine protein is more than 1.0 g; 12. Symptomatic metastasis of the central nervous system; 13. Pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptives; 14. Patient with mental illness or a history of psychotropic substance abuse; 15. HIV infection; 16. Before operation, AFP or PIVKA-2 increased, but not decreased to normal range; 17. HBV-DNA\>10\^3 copys/ml; 18. Other conditions that the investigators considered that not unsuitable for inclusion.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación