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A real-world, Prospective, Observational study of Regorafenib in the treatment of patients with Hepatocellular Carcinoma in the central area of China

A real-world, Prospective, Observational study of Regorafenib in the treatment of patients with Hepatocellular Carcinoma in the central area of China

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023703
Enrollment
Unknown
Registered
2019-06-08
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Case series:regorafenib

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
Progression free survival;

Secondary

MeasureTime 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

Public ContactYongshun Chen

Renmin Hospital of Wuhan University

yongshun2007@163.com+86 15286831671

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026