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Clinical Trial Summary

This study intends to prospectively enroll CNLC stage IIIb HCC cases with extrahepatic metastasis and intrahepatic lesions that are expected to be radical resected in several domestic clinical centers, and observe the OS and ORR, DCR, DOR, TTP and PFS of patients receiving hepatectomy combined with apatinib + carrelli pearl treatment.

Clinical Trial Description

Carrelizumab was approved by CFDA for second-line indication of hepatocellular carcinoma (HCC) in 2020. The AHELP study led to the CFDA approval of apatinib for second-line indication of HCC in 2021. RESCUE study (phase II) reported the efficacy and safety data of apatinib combined with carrelizumab in first-line (n= 70, 68.6% of CNLC stage IIIb) and second-line (n= 140, 75.8% of CNLC stage IIIb) in the treatment of advanced HCC. ORR was 46% and 25%, 2-year OS was 43% and 45%, median OS was 20.1 and 21.8 months, PFS was 6.4 and 5.5 months, and grade ≥3 adverse events were 78.6% and 76.7%, respectively. Local progression of intrahepatic lesions of HCC is the most important and direct cause of death, while extrahepatic metastases such as lung and bone metastases progress slowly and pose a much lower threat to life than intrahepatic lesions. For CNLC stage IIIb HCC, although liver resection is not recommended by officical guidelines, for cases with resectable intrahepatic lesions, a number of retrospective studies suggest that patients in the hepatectomy (even palliative resection) group had significantly better OS than those in the nonsurgical group, with a median OS of up to 32 months in the hepatectomy group, significantly higher than 19.2 months in atzuzumab plus bevacizumab or 20.1 months in apatinib plus carrelizumab. Previous retrospective studies in our center also suggest that some HCC patients with extrahepatic metastasis can still benefit from hepatectomy for long-term survival. Other studies suggested that the larger the preoperative diameter of HCC tumor, the greater the probability of postoperative lung metastasis. The more advanced the intrahepatic tumor or the larger the tumor load, the more likely the extrahepatic metastasis. Therefore, hepatectomy combined with targeted drugs +ICI may be the best treatment for HCC with extrahepatic metastasis and radical resection of intrahepatic tumor. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05062837
Study type Interventional
Source Guangxi Medical University
Contact Bang-De Xiang, Ph.D
Phone +86 771 5301253
Email [email protected]
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date November 1, 2021
Completion date January 31, 2023

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