UnknownPhase 1/2

Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

China30 participantsStarted 2023-02-02

Plain-language summary

This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of SBRT combined with cardonilizumab and lenvastinib in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Age: 18-70 years old;
✓. Eastern Cooperative Oncology Group (ECOG) -Performance Status(PS):0-2 points；
✓. Hepatocellular carcinoma was diagnosed according to histopathology or the 2022 diagnostic criteria for primary liver cancer；
✓. Expected survival period≥3 months;
✓. Liver function grade Child-Pugh A or better grade B (7 points);
✓. At least one measurable lesion:
✓. The Barcelona liver cancer staging system is stage C (BCLC-C), which meets one of the following conditions:

Exclusion criteria

✕. Patients diagnosed with hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibrolaminar cell carcinoma；
✕. Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation；
✕. Patients have hepatic encephalopathy (West Haven Standard Grade III, Level IV) or have moderate or severe ascites (i.e., patients requiring therapeutic puncture drainage) or have uncontrolled pleural or pericardial effusion；
✕. Patients have symptomatic, untreated, or progressive central nervous system (CNS) or leptomeningeal metastases.If all the following criteria are met, asymptomatic subjects with treated CNS lesions can be enrolled.

What they're measuring

Objective response rate(ORR)

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT06040177

SponsorFirst Affiliated Hospital of Guangxi Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-02

Contact for this trial

Ning Mo, professor

15289662269 369895025@qq.com

View on ClinicalTrials.gov More Hepatocellular Carcinoma Non-resectable trials