Camrelizumab Combined With Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Camrelizumab Combined With Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma：a Randomized, Open-label, Parallel, Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04521153
• Other study ID #: ZS-ZJ-SK-2020
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Jian Zhou, Doctor
• Phone: 008613801914007
• Email: zhou.jian[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 the rate of subjects with major pathological response and 3-year event-free survival (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 pathological complete response, EFS, overall survival and disease-free survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.

Description:

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. This trial includes subjects with CNLC Ib/IIa/IIb/IIIa HCC. All eligible subjects will be randomized (1:1) to experimental group or control group. In the experimental group, patients will be treated with following: neoadjuvant therapy (camrelizumab and apatinib, 2 cycles), radical surgery, postoperative TACE treatment, adjuvant therapy (camrelizumab and apatinib, 6 cycles); in the control group, patients will be treated with following: radical surgery, postoperative TACE treatment. The primary purpose of this study is to evaluate the rate of subjects with major pathological response and 3-year event-free survival (EFS) of camrelizumab combined with apatinib mesylate in the perioperative period of HCC. The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with pathological complete response, EFS, overall survival and disease-free survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable HCC. The safety and tolerability is also evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Volunteer to participate in this study and sign an informed consent form

2. Age 18~75 years old, no gender limit

3. Hepatocellular carcinoma confirmed by histopathology, cytology or imaging

4. CNLC stage Ib/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus

5. Child-Pugh score: A-B grade (=7 points)

6. ECOG PS score: 0-1 points

Exclusion Criteria:

1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time.

2. Currently accompanied by interstitial pneumonia or interstitial lung disease

3. Existence of active autoimmune disease or history of autoimmune disease and may relapse

4. Patients with active infection, unexplained fever =38.5? within 1 week before randomization, or baseline white blood cell count >15*10^9/L

5. Patients with congenital or acquired immune deficiencies (such as HIV-infected persons)

6. Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Immunotherapy
• Molecular Targeted Therapy

Intervention

Drug:
• Camrelizumab
Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery
• Apatinib Mesylate
Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery

Procedure:
• TACE treatment
TACE treatment
• Radical surgery
Radical surgery

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (17)

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year event-free survival (EFS)	EFS is defined as the time from randomisation to tumor progression, postoperative relaspse or metastasis, or death, which occur first.	3-year
Primary	The rate of subjects of major pathological response (MPR)	MPR is defined as less than 50% residual tumor after neoadjuvant therapy of camrelizumab and apatinib therapy.	30-day
Secondary	Overall survival (OS)	OS is defined as the time from randomisation to death.	3-year
Secondary	Disease-free survival (DFS)	DFS is defined as the time from surgery to postoperative relaspse or metastasis, or death, which occur first.	3-year
Secondary	Event-free survival (EFS)	EFS is defined as the time from randomisation to tumor progression, postoperative relaspse or metastasis, or death, which occur first.	3-year
Secondary	R0 resection rate	R0 resection rate	30-day
Secondary	Safety and toleraty	The incidence of adverse evetns, severe adverse events; surgery related safety.	30-day