Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellu… (NCT02403544) | Clinical Trial Compass
UnknownPhase 1
Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma
China30 participantsStarted 2013-09
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Criteria:
Inclusion Criteria:
* KPS≥80.
* Life expectancy≥16 months.
* Histopathologically or clinically diagnosed HCC.
* Barcelona-Clinic Liver Cancer (BCLC) 0-C without distant metastasis.
* The primary tumor is unresectable, inoperable or failed in other previous therapies.
* Child-pugh≤6 (Child A), Indocyanine green retention rate at 15min \<20%.
* HGb≥100g/L, WBC≥3×109/L, NEUT≥1.5×109/L, PLT≥75×109/L, Creatine≤1.5mg/dl (UNL), Bun≤30mg/dl, Alanine aminotransferase/Aspartate aminotransferase/Alkaline phosphatase≤2.5×UNL, TBil≤1.5×UNL, Prothrombin time≤1.5×UNL, INR≤1.5.
* No prior liver or upper abdomen radiation therapy.
* No previous history of allergic reaction attributed to fluorouracil or platinum drugs.
* Be conscious and could cooperate and comply with protocols for the study, such as simulation, smooth breathing and positioning for radiotherapy.
* Be ready to be followed up.
* Fulfill dosages requirement for targets and dose limits for organs at risk.
* The patient should be under anti-hepatitis-virus therapy if indicated.
* Sorafenib should be discontinued 7 days before the start of irradiation.
* Subjects informed of the diagnosis of advanced HCC who are fully informed about the content of the study by the investigator using the written consent form, and give written consent to participate in the study of their own free will.
Exclusion Criteria:
* KPS≤70.
* Existing distant metastasis.
* Child-Pugh≥7, Indocyanine green retention rate at 15min ≥20%.
* Primary t…
What they're measuring
1
Maximum Tolerated Dose (MTD) for capecitabine and oxaliplatin
Timeframe: up to four weeks after the end of the treatment.