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A real world study of the adjuvant therapy of apatinib mesylate tablet for high-risk postoperative recurrence of hepatocellular carcinoma

A real world study of the adjuvant therapy of apatinib mesylate tablet for high-risk postoperative recurrence of hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018175
Enrollment
Unknown
Registered
2018-09-04
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-09-10

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

Conditions

Liver cancer

Interventions

Case series:Taking apatinib mesylate tablets orally once a day, initial dose 250mg, 28 days is one medication cycle. The treatment ends when the patient develop cancer recurrence/metastasis or death.

Sponsors

Chinese People's Liberation Army (PLA) General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged=18years male and female; 2. Patients with hepatocellular carcinoma who have undergone surgical resection or local ablation(PEI or percutaneous puncture or intraoperative RFA); 3. Postoperative pathology suggested no residual lesion at the cutting edge; 4. Preoperative radiology (CT, MRI, PET-CT etc), intraoperative or postoperative pathology examination revealed one risk factor for recurrence at least: Group1: Tumor number =3; Group2: The differentiation level is III or IV. (Edmondson-Steiner Four-stage (I-IV) classification method ); Group3: The tumor thrombus of the hepatic vein, portal vein, bile duct or inferior vena cava should be visible to the naked eye or under the microscope and can be surgically removed, except for single tumor which diameter less than 2cm; Group4: AFP Elevated before surgery (=200ng/ml), and AFP =200ng/ml 1~2 months after surgery; Group5: Tumor rupture; Group6: There was no definite fibrous capsule or incomplete capsule between tumor and liver tissue; Group7: Satellite nodules are seen in the resection specimen; Group8: Special location tumor (For example: adjacent to the left, middle, right or inferior vena cava of the liver ). 5. Voluntarily join this study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to apatinib mesylate tablets and/or its excipients has been confirmed; 2. Pregnant or lactating women; 3. Apatinib contraindication; 4. The doctor considered the inclusion inappropriate.

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival;Time to recurrence;

Secondary

MeasureTime frame
Overall survival;1 year recurrence rate, 2 year recurrence rate, 3 year recurrence rate;Life quality score (EORTC QLQ-C30 V3.0 or HCC-18);

Countries

China

Contacts

Public ContactRong Liu

Chinese People's Liberation Army (PLA) General Hospital

liurong301@126.com+86 010-66937591

Outcome results

None listed

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