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A multicenter prospective cohort study for relapse prevention in patients with high-risk recurrence after primary hepatocellular carcinoma resection

A multicenter prospective cohort study for relapse prevention in patients with high-risk recurrence after primary hepatocellular carcinoma resection

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027953
Enrollment
Unknown
Registered
2019-12-07
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-03-23

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

Conditions

Hepatocellular carcinoma

Interventions

experimental group:Lenvatinib
control group:Blank

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. creatinine clearance> 40 mL / min 3. Child A: Total bilirubin = 28 g / L, AST, ALT, ALP = 1.5 X 10 ^ 9 / L, Hb> = 8.5g / L, PLT> = 75 X 10 ^ 9 / L 5. Blood coagulation function: INR 3 2) Maximum tumor diameter> 8cm 3) Unclear tumor boundary without complete envelope, (2) With gross portal vein, hepatic vein, or bile duct cancer thrombus; (3) Preoperative liver cancer rupture or liver cancer invasion of adjacent organs; 9. Understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with other malignancies; 3. Patients with mental illness; 4. Patients who participated in other clinical trials in the past three months; 5. Serious illness with non-malignant tumors can affect patient compliance or put patients at risk; 6. Patients treated with other targeted drugs, immunotherapy such as PD1 antibodies, FOLFOX systemic chemotherapy, Huaier granules after surgery; 7. Urine routine tips> 1 + proteinuria patients will receive a 24-hour urinary protein test, while patients with a 24-hour urine protein> = 1g will not qualify; 8. Have a history of sorafenib and lenvatinib before surgery; 9. Child scored B-C; 10. Patients with other tumor treatments such as radiotherapy and chemotherapy before surgery.

Design outcomes

Primary

MeasureTime frame
disease free survival, DFS;

Secondary

MeasureTime frame
overall survival, OS;Adverse reactions and safety;time to recurrence, TTR;

Countries

China

Contacts

Public ContactXiao Zhiyu

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

xiaozhiy@mail.sysu.edu.cn+86 13682283695

Outcome results

None listed

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