ITMCTR2100004340招募中1 期
A Prospective, Randomized, Double-Blind Study of Xiangsha Liujunzi Decotion Compared With Placebo in the First-Line Treatment of Unresectable Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
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
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •1. The patients aged 18 years or above are male or female;
- •2. Patients who meet the criteria for diagnosis and treatment of primary liver cancer (2017 Edition) issued by the national health and Family Planning Commission, and / or patients with advanced or metastatic HCC confirmed by pathology / cytology, are not allowed to undergo liver surgery, or recurrence and progression after surgery and / or other local treatment;
- •3. Patients who have not received the first-line systemic therapy (systemic chemotherapy, molecular targeting, immunotherapy and research therapy) for advanced or metastatic HCC before, including but not limited to systemic chemotherapy containing oxaliplatin, sorafenib, lenvastinib, PD-1 / PD-L1 antibody, etc.;
- •4. Patients who are more than 4 weeks away from the end of liver ablation or hepatic artery interventional therapy, and the related adverse reactions return to normal; patients who have gone beyond the standard for systemic adjuvant chemotherapy after surgery or other local treatment, need more than 6 months after the end of chemotherapy, and have disease progression and / or metastasis;
- •5. Patients who did not use modern Chinese medicine preparations with indications for liver cancer within 2 weeks before the first use of drugs included Delisheng injection, Kanglaite injection or soft capsule, Aidi or Kangsaidi injection, elemene injection / oral liquid, Huaier granule and Ganfule capsule / tablet, etc.;
- •6. Patients without blood transfusion or blood products, hematopoietic stimulating factor, albumin or blood products within 14 days before screening;
- •7. According to RECIST 1.1, patients with at least one measurable target lesion were defined as non lymph node lesions with the longest single diameter >= 10 mm, or lymph node lesions with the shortest diameter >= 15 mm. For lesions that had undergone ablation or hepatic artery intervention, CT / MRI examination must be performed, and according to RECIST 1.1 if the disease progression has been confirmed by the standard and the longest diameter is greater than or equal to 1.0 cm, it can be used as the measurable target lesion;
- •8. Patients with child Pugh liver function score <= 7;
- •9. Patients with normal function of main organs meet the following requirements: platelets >= 60 x 10^9 / L, hemoglobin >= 85g / L, white blood cells >= 3.0 x 10^9 / L; total bilirubin <= 1.5 times of upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 5 times ULN; albumin >= 28g / L; serum creatinine <= 1.5 times ULN, or creatinine clearance rate >= 50ml / min;
- •10. If HBV-DNA is more than or equal to 104 copies / ml (2000 IU / ml), antiviral and liver protective therapy must be given first, and only when HBV-DNA is less than or equal to 104 copies / ml (2000 IU / ml) can the patients be enrolled in the group; and antiviral drugs should be taken continuously, liver function and HBV load should be monitored;
- •11. For women of childbearing age, pregnancy test must be conducted within 7 days before treatment and the result is negative; for men of childbearing age, effective contraceptive measures should be taken during and within 3 months after treatment;
- •12. The subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up;
- •13. Subjects who did not participate in other clinical trials within 4 weeks before screening; those who failed in other trials but met the requirements of thi
排除标准
- •1. Imaging examination of HCC patients with huge liver tumor (>= 60% liver volume), or tumor thrombus in the main portal vein (occupying more than 50% of the vascular diameter), or tumor thrombus invading mesenteric vein or inferior vena cava;
- •2. Patients with moderate or more ascites of clinical significance need therapeutic abdominal puncture / drainage, or child Pugh score > 2;
- •3. Patients who received local anticancer therapy (including surgery, ablation, TACE or radiotherapy) or major surgery within 28 days before randomization;
- •4. Patients with cholangiocarcinoma and fibrolamellar cell carcinoma;
- •5. Patients with other malignant tumors in the past 5 years or at the same time, except for cervical cancer in situ, basal cell carcinoma and superficial bladder tumor (TA, tis, T1);
- •6. Pregnant or lactating women;
- •7. Patients with myocardial ischemia or myocardial infarction of CTCAE grade II or above, poorly controlled arrhythmia, and / or cardiac insufficiency of NYHA grade III-IV;
- •8. Patients who have received allogeneic organ transplantation before, including liver transplantation, or plan to receive liver transplantation during the trial period;
- •9. Patients with hepatic encephalopathy and / or hepatic nephropathy within 6 months;
- •10. Active hepatitis C, that is, patients with anti HCV positive or HCV-RNA positive and abnormal liver function;
- •11. HIV positive patients or severe infections requiring systemic treatment with antibiotics;
- •12. The patients who can't swallow, chronic diarrhea or intestinal obstruction obviously affect the drug taking and absorption;
- •13. Patients with a history of gastrointestinal bleeding within 6 months, or with a clear tendency of gastrointestinal bleeding, including local active ulcer lesions and positive fecal occult blood;
- •14. The patient has known active or suspected autoimmune diseases;
- •15. Patients with known central nervous system metastasis should be excluded by MRI;
- •16. Patients with obvious abnormal coagulation function: international normalized ratio (INR) > 1.5 or prothrombin time (PT) > 16 s;
- •17. Patients with a history of schizophrenia or psychotropic substance abuse;
- •18. Patients who are known to be allergic or intolerant to Xiangsha Liujunzi Decoction;
- •19. Patients with poor compliance;
- •20. Other conditions considered by the researchers to prevent patients from participating in the trial.
研究者
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