This is a single-arm, open, multicenter II phase clinical study to compare the efficacy and safety of HAIC combined with Apatinib and Camrelizumab in the treatment of unresectable middle-advanced MTM-HCC.
Macrotrabecular-massive hepatocellular carcinoma (MTM-HCC) is a special pathological subtype of liver cancer, characterized by vascular invasion, early recurrence and poor survival. For unresectable MTM-HCC, there are currently no prospectively clinically validated treatment options. As a local interventional treatment, hepatic arterial infusion chemotherapy (HAIC) has shown better efficacy and safety than traditional transcatheter arterial chemoembolization (TACE) in the treatment of unresectable HCC. In addition, HAIC has been widely used as an alternative to sorafenib in advanced HCC in the eastern Asia. Studies have also shown that the combination of Apatinib and Camrelizumab has also shown encouraging results, and patients are well tolerated. Therefore, we designed HAIC combined with Apatinib and Camrelizumab for the exploratory study of unresectable MTM-HCC, in order to provide a safe, effective and tolerable option for patients with MTM-HCC, prolong their survival time and improve their quality of life. Study population: 38 untreated patients with unresectable middle-advanced macrotrabecular-massive hepatocellular carcinoma Treatment: All patients were treated with standard HAIC (administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries) on the first day (D1). Immediately after the first HAIC, the liver function was reexamined. If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC. The combination of drugs for 3 weeks is a cycle.The treatment continued until the patient developed the disease or met the other criteria for terminating the study. Curative effect evaluation： The tumor condition was evaluated by imaging method at D28 (±7 days) after each HAIC, until the curative effect was evaluated as PD or unsuitable for further treatment. After 3 times of HAIC treatment, the tumor efficacy was evaluated every 8 weeks (±3 days) after the first HAIC treatment until disease progression (Response Evaluation Criteria In Solid Tumors（RECIST）1.1) or death (during treatment) or toxicity intolerable. The tumor treatment and survival status after disease progression were recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.
Apatinib(250 mg; p.o.; qd.); camrelizumab (200 mg; iv drip; q3w) If the liver function was grade Child-Pugh A, Camrelizumab was given intravenously once every 3 weeks (D1) on the same day, 200mg/, once every 3 weeks (D1). Apatinib capsule was given orally to 250mg within half an hour after breakfast on the second day (D2) after the first HAIC. The drug was given continuously once a day and stopped on the same day of each HAIC.
Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGObjective remission rate (ORR)
Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR).
Time frame: After the first HAIC treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 1 year
Progression-free survival (PFS)
Refers to the date from the date of admission to the date of the first progression of disease or death of any cause.
Time frame: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Disease control rate (DCR)
Percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy
Time frame: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Total Survival time (OS)
Refers to the date from the date of admission to the date of death of any cause
Time frame: Through study completion, an average of 2 year
Incidence of adverse events and toxicities of Apatinib in combination with Camrelizumab
Categorized according to NCI Common Toxicity Criteria version 5.0. Summarized in terms of type, severity (grade 1-5), and dose level in tabular format.
Time frame: Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).
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