Clinical study for the first-line treatment of advanced hepatocellular carcinoma with anrotinib hydrochloride capsule

Phase 1

• Conditions: Hepatocellular carcinoma

• Registration Number: ITMCTR1900002329
• Lead Sponsor: Guilin Traditional Chinese Medicine Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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:
(1) blood routine examination :(no blood transfusion, no g-csf, no drug correction within 14 days before screening)
HB 90 g/L or higher;
The ANC acuity 1.5 x 10^9 / L;
PLT acuity 80 x 10^9 / L;
(2) biochemical examination :(ALB was not transfused within 14 days)
Propagated 29 g/L or higher;
ALT and AST < 5 uln;
1.5 ULN TBIL or less;
Creatinine 1.5 or less ULN.
(only one of the two indexes of albumin and bilirubin in child-pugh rating is 2 points)
11. Women of child-bearing age must undergo a pregnancy test (serum or urine) within 7 days of enrollment, which is negative, and are willing to use an appropriate method of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgical sterilization should be performed, or an appropriate method of contraception should be agreed during the trial and eight weeks after the last administration of the test drug;
12. Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.

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.
11. Abnormal coagulation function (INR > 1.5 or PT > ULN+4 seconds), bleeding tendency or receiving thrombolytic or anticoagulant treatment;
12. Patients with central nervous system metastasis or known brain metastasis;
13. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function;
14. Urine routine examination showed urine protein ++ or confirmed the quantitative urine protein of 24 hours > 1.0g;
15. Received treatment with a potent CYP3A4 inhibitor within 7 days before the study, or with a potent CYP3A4 inducer within 12 days before the study;
16. Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures;
17. A history of mental illness or substance abuse;
18. Patients with bone metastases received palliative radiotherapy (> 5% bone marrow region) within 4 weeks prior to the study.

Study & Design

• Study Type: Observational study
• Study Design: Not specified