ITMCTR2200006060尚未招募1 期
China academy of Innovation Fund (No. CI2021A01804)
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •? Age from 18 to 75 years old, male and female;
- •? Patients with locally advanced or metastatic hepatocellular carcinoma diagnosed with definite pathological diagnosis cannot be treated with liver surgery and/or other local treatment (ablation or hepatic artery intervention), or recurrence and progression after surgery and/or other local treatment;
- •? No prior first-line systemic therapy for advanced or metastatic hepatocellular carcinoma;
- •?At least one measurable target lesion (the longest single diameter =10mm non-lymph node lesion, or the short diameter =15mm lymph node lesion); For the lesions after previous local treatment such as ablation, radiotherapy or hepatic artery interventional therapy, CT/MRI examination must be performed and disease progression must be confirmed according to mRECIST standards, with the longest diameter =1.0cm, which can also be used as measurable target lesions.
- •? After liver surgery > 3 months, ablation or hepatic artery interventional therapy > 4 weeks, and related adverse reactions returned to normal; If patients who have gone beyond the norm of systemic adjuvant chemotherapy or targeted therapy after surgery or other local therapy need > 6 months to end chemotherapy or targeted therapy and develop disease progression and/or metastasis;
- •?Child-Pugh liver function score is A or better B (=7 points);
- •?ECOG physical status score was 0-1;
- •?The expected survival time was =12 weeks;
- •? Within 2 weeks before the first administration of this study, no modern Chinese medicine preparations with liver cancer indication were used: Kanglet injection/soft capsule, Aidi or Kangsaidi injection, elemene injection/oral liquid, Huaier granule, Bufalin and Ganforle capsule/tablet, etc.
- •? The functions of major organs are basically normal, meeting the following requirements:
- •Bone marrow: Neutrophil absolute count =1.5×109/L, platelet =80×109/L, hemoglobin =90g/L;
- •Liver: total bilirubin =1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase =5 times the upper limit of normal value, albumin =30g/L;
- •Kidney: serum creatinine =1.5 upper limit of normal value, or creatinine clearance rate =50mL/min;
排除标准
- •? If the ascites with moderate or higher volume is clinically significant, that is, therapeutic peritoneal puncture/drainage is required, or child-Pugh score of this index is > 2;
- •? Hepatobiliary duct cell carcinoma and fibrolamellar cell carcinoma; Patients with previous or co-existing cancers with primary foci or histology completely different from hepatocellular carcinoma, but who have been cured of malignancy 5+ years ago, are eligible for inclusion;
- •? Pregnant or lactating women;
- •? Patients with hypertension who cannot be well controlled by antihypertensive drugs (systolic blood pressure > 140mmHg, diastolic blood pressure > 100mmHg);
- •? The occurrence of hepatic encephalopathy and/or hepatic nephropathy within 6 months;
- •? Other conditions considered by the investigator to prevent patients from participating in the study.
研究者
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