A prospective, randomized controlled, open-label study of adjuvant capecitabine after CK19-related liver cancer surgery

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000041418

Enrollment

Unknown

Registered

2020-12-25

Start date

2020-08-05

Completion date

Unknown

Last updated

2021-03-15

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

Conditions

Hepatocellular Carcinoma

Interventions

experiment group with CK19 positive:Oral capecitabine

experiment group with CK19 positive:TACE

Control group with CK19 negative:Oral capecitabine

Control group with CK19 negative:TACE

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years; 2. Patients with resectable primary HCC and postoperative pathology report CK19 (- + + +). 3. Subjects with child Pugh a or B liver function; 4. Subjects with ECoG PS 0-1; 5. Patients whose expected survival is more than 3 months; 6. Patients whose ALT and AST do not exceed 2.5 times the upper limit of normal value; 7. Patients with neutrophil count >= 1.5 x 10^9 / L; 8. Subjects with hemoglobin concentration >= 85g / L; 9. Subjects with serum albumin concentration >= 30g / L; 10. Subjects with platelet >= 80 x 10^9 / L; 11. Subjects with creatinine < 150 umol / L; 12. The patients and his authorized legal representatives understand and agree to sign the informed consent, and agree to follow-up according to the design of this study.

Exclusion criteria

Exclusion criteria: 1. Patients who have received capecitabine treatment, allergy or severe adverse reactions of 5-FU within 5 years. 2. Patients who have not fully recovered after operation or have received chemotherapy, targeted or immunosuppressive drugs in the past; 3. Patients with TACE contraindications; 4. Patients with severe esophageal varices and hemorrhagic disease or active gastrointestinal bleeding within 2 weeks after enrollment; 5. Pregnant or lactating subjects; 6. Patients with tumor rupture and hemorrhage; 7. Patients with other cancers within 5 years.

Design outcomes

Primary

Measure	Time frame
time to recurrence, TTR;Disease-free survival DFS;	—

Secondary

Measure	Time frame
Overall survival;	—

Countries

China

Contacts

Public ContactXiang Bangde

Cancer Hospital Affiliated to Guangxi Medical University

xiangbangde@gxmu.edu.cn+86 13707886124

Outcome results

None listed

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