ITMCTR2100005192尚未招募2 期
A phase II, open, single arm, single center study to evaluate the efficacy and safety of compound Huangdai tablets for advanced liver cancer
Changhai Hospital, Navy Military Medical University, Shanghai0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Treatment study
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •1. 18-75 years old (inclusive), regardless of gender;
- •2. Meet the clinical diagnostic criteria of the standard for diagnosis and treatment of primary liver cancer (2019 Edition) or the diagnosis of hepatocellular carcinoma by histopathology or cytology;
- •3. Those who cannot accept or are unwilling to accept palliative surgery and have at least one measurable lesion (according to RECIST version 1.1, the long diameter of spiral CT scanning of the measurable lesion is = 10mm or the short diameter of enlarged lymph nodes is = 15mm)
- •4. Previous systemic chemotherapy (oxaliplatin based chemotherapy) or targeted therapy (such as sorafenib, renvatinib, etc.) with drug resistance or intolerance. Drug resistance is defined as disease progression or recurrence during or after treatment, and receiving chemotherapy for at least one cycle and targeted therapy for at least 14 days. Intolerance is defined as grade 4 or higher hematotoxicity, grade 3 or higher non hematotoxicity, or grade 2 or higher toxicity.
- •5. Child Pugh: grade A-B, BCLC stage: stage B-C;
- •6. ECoG PS score: 0-3;
- •7. If the liver and kidney organs function normally, they meet the following standards:
- •a) Blood routine examination: ? HB = 90 g / L; ?ANC=1.5 × 109/L ?PLT=75 × 109/L
- •b) Biochemical examination: ? ALB = 29 g / L; ? ALT and AST < 5uln; ?TBIL=2ULN; ? Creatinine = 1.5uln.
- •8. Estimated survival time = 12 weeks;
- •9. Unwilling or unable to accept second-line targeted and / or immunotherapy
- •Voluntarily participate in the clinical trial, sign the informed consent form, and be able to complete the follow-up
排除标准
- •1. Patients known to be allergic to the study drug or active ingredient;
- •2. The imaging findings of liver cancer correspond to any of the following: a) = 50% HCC; b) Clear invasion of bile duct; c) Portal vein invaded the main portal vein branch (VP4);
- •3. Mixed cell carcinoma and fibrous lamellar cell carcinoma; Other untreated malignant tumors in the past (within 5 years) or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
- •4. Those who have received the following treatment within 4 weeks before enrollment: surgery, radiotherapy, chemotherapy, local treatment (hepatic artery chemoembolization, hepatic artery infusion chemotherapy, radiofrequency ablation, cryoablation or percutaneous absolute ethanol injection), targeted therapy and biotherapy;
- •5. Ascites with clinical symptoms, i.e. therapeutic abdominal puncture or drainage;
- •6. Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
- •7. Arrhythmias with myocardial ischemia or myocardial infarction above grade II and poor control (including QTc interval = 450 ms for men and = 470 MS for women);
- •8. Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- •9. According to NYHA standard, grade III ~ IV cardiac insufficiency or color Doppler echocardiography: LVEF (left ventricular ejection fraction) < 50%;
- •10. Patients who have a history of gastrointestinal hemorrhage or have a clear tendency of gastrointestinal bleeding within 3 months before enrollment, such as esophageal varices with bleeding risk, local active ulcer lesions and fecal occult blood = (+) shall not be enrolled; If stool occult blood (+), gastroscopy is required;
- •11. The subject has immune deficiency disease or history, or has a history of organ transplantation, or is ready for liver transplantation;
- •12. There are many factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect the taking and absorption of drugs);
- •13. Patients with central nervous system metastasis or known brain metastasis;
- •14. Any subject cannot be evaluated by three-phase liver CT or three-phase liver MRI due to allergy to CT and MRI contrast agents or other contraindications;
- •15. Have a history of mental illness or psychotropic substance abuse;
- •16. Patients who are participating in other clinical studies or receiving any other research treatment within 30 days before enrollment;
- •17. Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
- •In the judgment of the investigator, the patients are not suitable for inclusion in this study.
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