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A real world study on the adjuvant therapy of Camrelizumab combined with Apatinib in high-risk patients with liver cancer recurrence after operation

A real world study on the adjuvant therapy of Camrelizumab combined with Apatinib in high-risk patients with liver cancer recurrence after operation

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039728
Enrollment
Unknown
Registered
2020-11-06
Start date
2020-11-06
Completion date
Unknown
Last updated
2021-02-16

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

Conditions

Liver cancer

Interventions

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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 ). Group9: HBV infected persons without antiviral treatment before, or after antiviral treatment, HBV DNA > 106 copies / ml, or combined with HCV. Group10: Combined with cirrhosis. Group11: Diameter of single tumor > 5cm. 5. The investigator evaluated the possibility of receiving treatment with Camrelizumab with Apatinib 6. Voluntarily join this study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation; 2. Patients with other tumors; 3. Confirmed pregnant or lactating women; 4. Participating in any research with intervention measures outside the conventional clinical trials; 5. The investigator considered the inclusion inappropriate.

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival;

Secondary

MeasureTime frame
Time to recurrence;one year recurrence rate, two year recurrence rate, three year recurrence rate;Overall survival;Quality of life score;Safety;

Countries

China

Contacts

Public ContactRong Liu

Chinese PLA General Hospital

lirong301@126.com+86 10-66937591

Outcome results

None listed

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