This is a phase I study to evaluate the safety of concurrent chemoradiation combining radiotherapy (IGRT) with two cytotoxic agents, capecitabine and oxaliplatin in patients with advanced or inoperable hepatocellular carcinoma.
In this phase I study, patients with advanced or inoperable hepatocellular carcinoma, or those failed other strategies will be recruited. The primary tumor and nearby metastatic nodes will be irradiated with Image-Guided Radiation Therapy (IGRT) mostly with conventional fractions. During the course, oral capecitabine and intravenous oxaliplatin will be given concurrently. The maximum tolerated dose (MTD) for the two drugs will be determined during escalation according to the occurrence of dose limiting toxicities (DLT).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
IGRT: 45 to 54Gy, 1.8-3Gy per fraction.
Capecitabine: by oral, D1-14, every 21 days, 600mg/m2 bid per day in level 1, and then escalated every another dose level.
Oxaliplatin: intravenously, D1 and D8, every 21 days, 30mg/m2 per day in level 1, and then escalated every another dose level.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGMaximum Tolerated Dose (MTD) for capecitabine and oxaliplatin
Time frame: up to four weeks after the end of the treatment.
Dose Limiting Toxicity (DLT)
Time frame: up to four weeks after the end of the treatment.
In field recurrence rate (LR) or local failure free survival (LFFS)
Time frame: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Intrahepatic failure rate or intrahepatic failure free survival (IHFFS)
Time frame: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Extrahepatic failure rate or extrahepatic failure free survival (EHFFS)
Time frame: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Overall survival
Time frame: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Tumor response rate including complete response and partial response rates
Time frame: 1 month and 3 month from the end of CCRT
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