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Clinical research of capecitabine in the adjuvant chemotherapy of postoperative liver cancer

Clinical research of capecitabine in the adjuvant chemotherapy of postoperative liver cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-08000160
Enrollment
Unknown
Registered
2008-09-20
Start date
2003-08-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Primary liver cancer after surgery

Interventions

Experimental group:Regular postoperative therapy is the same as the control group. Intake of capecitabine: 1000mg/m2, Bid, oral intake in 30 minutes after meals.
Control group:Regular postoperative therapy includes medicines for liver supporting and preventive interventional treatment and immunotherapy.

Sponsors

Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Those who haven't participate in other clinical trials or chemotherapy; 2. Liver function grade > Child B, whithout cancer embolus in the main portal veins or metastasis; 3. Age: 18-70 years old, no gender restrict; 4. Adjuvant therapyaccepted more than 6 months ago; 5. Pathologically diagnosed as hepatocellular carcinoma with qualitative data; 6. Liver function recovers to normal after surgery, Child Grade I, AFP 9.0g/dl, WBC>4000/ml, PLT>100000/ml; 8. GPT, GOT=70 scores; 9. Predicted survival > 6 months; 10. Participants sign the informed consent form before enrollment.

Exclusion criteria

Exclusion criteria: 1. Age 75years; 2. Pregnant or breast-feeding women; 3. Allergic or seriously response to 5-Fu; 4. Peripheral and central nervous abnormality and psychiatric disease; 5. Abnormal ECG or evident heart disease; 6. Severe infection, sepsis, metabolic disturbance or diabetes; 7. Active digestive ulcer needs treating or absorption disorder; 8. Malignant tumor of other sites in recent 5 years or meatastasis to cerebrum and bone.

Design outcomes

Primary

MeasureTime frame
Liver function, blood routine, AFP, B ultrasound, take CT or MRI periodically and DSA if necessary.;

Secondary

MeasureTime frame
Liver and renal function, adverse enent;

Countries

China

Contacts

Public ContactShen Feng, Yong Xia
xiay99@21cn.com+86 0 13601608920

Outcome results

None listed

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