ITMCTR1900002329
Not yet recruiting
Phase 1
Clinical study for the first-line treatment of advanced hepatocellular carcinoma with anrotinib hydrochloride capsule
Guilin Traditional Chinese Medicine Hospital0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Guilin Traditional Chinese Medicine Hospital
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 18 years;
- •2\. Patients with HCC who strictly comply with the clinical diagnostic criteria of the standard for diagnosis and treatment of primary liver cancer (2017 edition) or who are confirmed by histopathological or cytological examination.
- •3\. No palliative surgery or radiotherapy is acceptable. Or postoperative recurrence and metastasis.
- •4\. Patients who are not willing to receive TACE surgery or are not suitable for TACE surgery. Patients with recurrence or metastasis after TACE.
- •5\. At least one measurable lesion (as per RECIST 1\.1\), which had a helical CT scan with a length diameter of 10 mm or a enlarged lymph node with a short diameter of 15 mm.
- •6\. Child\-pugh liver function rating: grade A or better grade B (7\);
- •7\. BCLC stage was b\-c stage;
- •8\. ECOG PS score within 1 week before enrollment: 0\-1;
- •9\. Expected survival 12 weeks;
- •10\. Normal functioning of major organs means that they meet the following criteria:
Exclusion Criteria
- •1\. Received any local treatment (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) within 4 weeks prior to the study;
- •2\. Hepatobiliary duct cell carcinoma, mixed cell carcinoma and fibrolamellar cell carcinoma are known; Previous (within 5 years) or concurrent with other uncured malignancies, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- •3\. Patients preparing for liver transplantation (except those with previous liver transplantation);
- •4\. Ascites with clinical symptoms, i.e. therapeutic peritoneal puncture or drainage, or child\-pugh score \> 2;
- •5\. Patients with hypertension who cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
- •Level is above 6\. With ? myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher);
- •7\. According to the NYHA standard III \~ IV level cardiac insufficiency or heart colour to exceed examination: LVEF, left ventricular ejection fraction \< 50%;
- •8\. Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, which obviously affect drug taking and absorption);
- •9\. Patients with a history of gastrointestinal bleeding or a clear gastrointestinal bleeding tendency in the past 6 months, such as esophageal varices with bleeding risk, local active ulcer lesions, and fecal occult blood (\+\+) were not enrolled;
- •10\. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred in the 28 days before the study.
Outcomes
Primary Outcomes
Not specified
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