RecruitingPhase 3NCT05613478

Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma

Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma: a Randomized, Open-label, Parallel, Multicenter Trial


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

130 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%\~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The primary purpose of this study is to evaluate 2 year event-free survival(2y-EFS) of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment — camrelizumab (an immunotherapy drug), apatinib (a targeted drug that blocks blood vessel growth), and TACE (a procedure that delivers chemotherapy directly to the liver) — in people with liver cancer before and after surgery. **You may be eligible if...** - You are 18 or older with liver cancer (hepatocellular carcinoma) confirmed by biopsy, lab, or imaging - Your liver cancer is at an intermediate or advanced local stage (specific Chinese staging criteria apply) - Your liver function is reasonably preserved (Child-Pugh grade A) - Your general health score is 0 or 1 (meaning you are active and able to care for yourself) **You may NOT be eligible if...** - You have a mixed or rare type of liver cancer (such as cholangiocarcinoma or fibrolamellar carcinoma) - You have another active cancer - You have active autoimmune disease or a history that may flare - You have a serious current infection or fever - You have HIV or another immune deficiency - You are allergic to immunotherapy or anti-angiogenesis drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab

Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery

DRUGApatinib Mesylate

Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery

PROCEDURERadical surgery

Radical surgery

PROCEDUREPreoperative TACE treatment

TACE treatment before preoperative camrelizumab combined with apatinib mesylate

DRUGCamrelizumab

Camrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery

DRUGApatinib Mesylate

Apatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery


Locations(1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

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NCT05613478


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