Macrotrabecular Massive Hepatocellular Carcinoma Clinical Trial
Official title:
A Single-arm, Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Apatinib and Camrelizumab in the Treatment of Unresectable Macrotrabecular-massive Hepatocellular Carcinoma
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. ;