The Safety and Maximum Tolerated Dose of Axitinib in Combination With Radiotherapy for HCC

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the maximal tolerated dose (MTD) of axitinib in combination with RT for advanced HCC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Treatments: Axitinib

Criteria

Inclusion Criteria:

• Age of 20-85 years, with ECOG performance 0-2.

• Advanced hepatocellular carcinoma (HCC), histologically or clinically diagnosed. (Multiple tumors, portal vein thrombosis, nodal metastasis or distant metastasis is allowed.)

• Unsuitable for resection, liver transplantation, radiofrequency ablation (RFA) or transarterial chemoembolization (TACE), or recurrent / refractory after prior local-regional treatment.

• ≥ One measurable tumor.

• Child-Pugh score A or B.

• Patients who fulfill all of the following criteria:

1. Serum total bilirubin ≤ 3 mg/dL

2. Serum alanine transaminase (ALT) ≤ 5 times ULN

3. INR ≤ 2.20

4. Platelet count ≥ 50,000 /mm3

5. WBC count ≥ 3,000 /mm3 or ANC ≥ 1,500 /mm3

6. Serum creatinine ≤ 2.0 mg/dL

• Normal thyroid function confirmed.

• Absence of grant for sorafenib.

• Sorafenib failure or intolerability (if ever used).

Exclusion Criteria:

• Considered to have high risk of bleeding (e.g. active peptic ulcer, unstable esophageal/gastric varices, history of aneurysm, and requirement of anticoagulant therapy).

• Pre-existing uncontrolled hypertension (systolic >140 mmHg, diastolic >90 mmHg) or proteinuria ≧500 mg/24 hours.

• Prior history of coronary artery disease.

• The patient is participating in other clinical trials.

• Pregnant women.

• Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

• Patients with non-healing wound.

• Requiring the use of potent CYP3A4/5 inhibitors or inducers (see Appendix).

• Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.