Postoperative adjuvant treatment with Capecitabine postpones recurrence of hepatocellular carcinoma after curative resection: a randomized controlled trial

A prospective randomized controlled trial comparing recurrence outcome of adjuvant capecitabine therapy versus no adjuvant therapy for patients with hepatocellular carcinoma after curative resection

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000574246

Enrollment

Registered

2009-07-14

Start date

2003-08-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Postoperative recurrence of hepatocellular carcinoma (HCC) is a major problem that hampers the efficacy of surgical resection. To date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective for HCC. We conducted a randomized controlled trial to investigate whether postoperative adjuvant therapy with capecitabine could inhibit the recurrence of HCC after radical resection.

Interventions

Beginning 3 to 4 weeks post operation, the capecitabine group received two weeks of capecitabine oral tablet at 1000 mg/m2, twice a day, 30 min after breakfast and dinner (Xeloda, 500 mg/tablet, Roche, Shanghai, China) followed by one week of rest. This three week regimen was repeated for a total of 4 to 6 cycles.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Patients whose age ranged from 18 to 70 years, with histologically proven hepatocellular carcinoma, and who underwent curative hepatectomy with less than 50% of the liver and with a tumor-free resection margin greater than 1 cm ;a postoperative decline of alpha-fetoprotein (AFP) level to less than 20 micro g/L; Child-Pugh class A; normalized hepatic function (glutamic pyruvic transaminase/glutamic oxaloacetic transaminase (GPT/GOT) equal to 2 times the upper normal limit; total serum bilirubin less than 34.2 micro mol/L); normal renal function and hematological parameters (serum creatinine less than 132 micro mol/L; white blood cell (WBC) count equal to 2500×109/L; platelet count (PTL) equal to 40×109/L); life expectancy longer than 6 months; Karnofsky Performance Scale (KPS) score egual to 70.

Exclusion criteria

Prior therapy with capecitabine, concomitant chemotherapy, allergy or history of severe adverse reactions to 5-fluoro-2,4(1H,3H)pyrimidinedione, bone or cerebral metastases, and malignant tumors in other regions of the body over the previous five years; peripheral neuropathy, history of central nervous system diseases, abnormal electrocardiogram findings, psychiatric disorders; severe cardiac, metabolic and/or infectious diseases; active peptic ulcer disease requiring treatment, absorption disorders, or upper digestive tract disorders; Pregnant or lactating females and pre-menopausal women without using contraception.

Outcome results