Abstract 340TiP
Background
Hepatocellular carcinoma (HCC) is the most common malignancy with high rates of recurrence and metastasis after radical resection. Vascular invasion, including portal vein tumor thrombus (PVTT) and microvascular invasion (MVI), and microsatellite lesions are two significant risk factors of postoperative recurrence and metastasis for HCC. Therefore, it is necessary to discover adjuvant therapies for patients with these risk factors. Anti-angiogenesis therapy combined with immunotherapy has demonstrated clinical benefits in multiple advanced solid neoplasms, including HCC. An exploratory phase Ib study (NCT02942329) proved that combined therapy of apatinib (250mg QD) and anti-PD-1 drug, SHR-1210 (200mg Q2W) was well tolerated and had preliminary efficacy in advanced HCC.
Trial design
This multicenter, randomized, controlled, phase II study will evaluate the safety and efficacy of adjuvant combined therapy of apatinib and anti-PD-1 drug, SHR-1210, compared with hepatic arterial infusion (HAI) chemotherapy, in patients with HCC at high risk of recurrence after radical resection. 200 patients, aged >18 years, Child-Pugh score 0 or 1, with histologically confirmed primary HCC, BCLC stage A or B diseases that are radical resected without other prior therapy for HCC and who are found to have microsatellite lesions, microvascular invasion or PVTT involved in second-order branch or above by preoperative imaging examination or postoperative pathological findings will be recruited and randomized (1:1) to receive apatinib (250mg QD) and SHR-1210 (200mg Q2W) for 6 months, or 2 times of standard HAI treatments (epirubicin 80-100mg or epirubicin 50mg+oxaliplatin 50mg). The primary endpoint is to compare recurrence-free survival and secondary endpoints include overall survival, safety, 1,2,3-year recurrence rate and Quality of Life score (QoL). Survival follow-up will continue for up to 3 years. The study is ongoing.
Clinical trial identification
NCT 03839550.
Legal entity responsible for the study
National Cancer Center/Cancer Hospital.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
107P - The efficacy of adjuvant chemotherapy according to the risk classification of recurrence based on the systemic inflammatory markers in patients with colorectal cancer liver metastases
Presenter: Masatsune Shibutani
Session: Poster display session
Resources:
Abstract
108P - Influence of liver metastasis locations on overall survival in patients with colorectal cancer
Presenter: Takayuki Sone
Session: Poster display session
Resources:
Abstract
109P - 18F-FDG PET/CT textural features as predictors of outcomes in patients with primary advanced colorectal cancer
Presenter: Jing Yang
Session: Poster display session
Resources:
Abstract
110P - D3 lymph node dissection may be necessary in clinical stage I right colon cancer
Presenter: Woong Bae Ji
Session: Poster display session
Resources:
Abstract
111P - Is preoperative chemoradiotherapy necessary for all patients with upper rectal cancer: One center retrospective study
Presenter: Jasur Madyarov
Session: Poster display session
Resources:
Abstract
112P - A retrospective analysis of the association between perioperative, post adjuvant carcinoembryonic antigen level and prognosis in stage III colorectal cancer
Presenter: Ryotaro Kozuki
Session: Poster display session
Resources:
Abstract
113P - Dicer contributes to chemoresistance in colorectal cancer via regulating a set of miRNAs and their downstream mRNAs
Presenter: Liang-Yi Hung
Session: Poster display session
Resources:
Abstract
114P - Efficacy and safety of the combination of bevacizumab with raltitrexed-based chemotherapy as second-line therapy in patients with metastatic colorectal cancer (mCRC): An interim analysis of a multicenter phase II trial
Presenter: Jun Zhu
Session: Poster display session
Resources:
Abstract
115P - Expression of Ki-67 as a prognostic factor in patients with colorectal cancer
Presenter: Kuantkan Zhabagin
Session: Poster display session
Resources:
Abstract
116P - Clinical significance and converionrate relevance of RAS genetic mutation analysis for unresectable colorectal liver metastases: A single-center retrospective study
Presenter: Meiling Ji
Session: Poster display session
Resources:
Abstract