Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years; 2. Diagnosis of primary hepatocellular carcinoma by CT, MRI and/or pathology, AFP, PIVKA-II, etc.; 3. Unable to be surgically removed; 4. Recurrent or metastatic hepatocellular carcinoma after surgery and/or interventional therapy; 5. Hepatocellular carcinoma after failed treatment of First-line chemotherapy or sorafenib.
Exclusion criteria
Exclusion criteria: 1. Patients who have been confirmed allergic to regorafenib and/or its excipients; 2. Patients with hypertension that cannot be reduced to normal range by antihypertensive drug treatment (systolic pressure >140 mmHg, diastolic pressure >90 mmHg),or coronary heart disease above Grade I, Grade I arrhythmia (including extended QTc period male >450 ms, female >470 ms) and I-grade cardiac insufficiency, or positive urinary protein ; 3. Having a variety of factors affecting oral drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 4. Patients with a clear tendency to bleed, including the following conditions: local active ulcer lesions, and stool latent blood (+ +), history of black stool or hemorrhage in 2 months; 5. Abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency; 6. Pregnant or lactating women; 7. Having an acute infection needs to be treated with antibiotics; 8. Patients who have participated in clinical trials of other drugs within four weeks; 9. According to the researcher's judgment, there is accompanying disease harming to the patients safety or completion of the study; 10. The researchers do not consider it appropriate to be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Duration of response;Objective response rate;Disease control rate;Quality of life score;Safety of the drug;Other analytical indicators; | — |
Countries
China
Contacts
Renmin Hospital of Wuhan University