Study Design:
This is a pilot study with a single arm in a single centre assessing safety and efficacy of durvalumab in combination with bevacizumab and HAIC followed by SBRT. This study will be conducted in selected patients with intermediate or advanced stage HCC not amenable to curative therapy. Approximately 30 patients will be enrolled and receive treatments.
Primary Objectives:
To evaluate the possibility of HAIC plus durvalumab and bevacizumab followed by SBRT as conversion therapy for HCC.
Secondary Objective(s):
To evaluate the efficacy of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC.
To evaluate the safety of HAIC plus durvalumab and bevacizumab followed by SBRT for HCC.
Exploratory Objective(s):
Evaluate the consistency of imaging CR and pathological CR in resected patients, and explore biomarkers associated with prognosis .
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Age > 18 years.
Confirmed HCC based on histopathological findings from tumor tissues.
HCC newly diagnosed or recurrent with a history of surgery or ablation, not amenable to curative surgery or transplantation.
Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or infiltrative-type HCC.
Patients with PVTT classified as VP3 (involving first-order portal branches) or VP4 (involving the main portal trunk or contralateral/bilateral branches) were excluded from the study.
Prior radiotherapy to the liver or upper abdomen.
Participation in another clinical study with an investigational product.
Single group
Durvalumab
Drug1120mg, iv, q3w
Bevacizumab
Drug15mg/kg, iv, q3w
HAIC of FOLFOX
DrugHAIC (FOLFOX): oxaliplatin 100mg/m2, 4h, day 1 + leucovorin 300mg/m2, 2h, day 1 + fluorouracil 500mg/m2, 20min, day 1 + fluorouracil 1500mg/m2, 20h, q3w
Conversion rate
Overall response rate (ORR) measured by RECIST v1.1, mRECIST.
Pathological complete response (pCR) for patients received resection.
Major pathologic response (MPR) for patients received resection.
AE
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