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Trial Title:
Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma
NCT ID:
NCT05613478
Condition:
Hepatocellular Carcinoma
Immunotherapy
Preoperative
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Apatinib
Chlorotrianisene
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg,
q3w (at least 6 cycles) after radical surgery
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Apatinib Mesylate
Description:
Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and
250mg, qd (at least 6 cycles) after radical surgery
Arm group label:
Experimental group
Intervention type:
Procedure
Intervention name:
Postoperative TACE treatment
Description:
TACE treatment after radical surgery
Arm group label:
Experimental group
Arm group label:
Radical surgery
Intervention type:
Procedure
Intervention name:
Radical surgery
Description:
Radical surgery
Arm group label:
Experimental group
Arm group label:
Radical surgery
Intervention type:
Procedure
Intervention name:
Preoperative TACE treatment
Description:
TACE treatment before preoperative camrelizumab combined with apatinib mesylate
Arm group label:
Experimental group
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 recurrence-free survival (RFS) 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), overall survival and 12-months recurrence-free
survival of camrelizumab combined with apatinib mesylate in the perioperative period of
resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Detailed 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 ( perioperative TACE treatment，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 recurrence-free survival (RFS) 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), overall survival and 12-months recurrence-free
survival of camrelizumab combined with apatinib mesylate in the perioperative period of
resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Volunteer to participate in this study and sign an informed consent form.
- Age ≥18 years old, no gender limit.
- Hepatocellular carcinoma confirmed by histopathology, cytology or imaging.
- CNLC stage Ib (single tumor with diameter ≥8 cm)/IIa/IIb/IIIa hepatocellular
carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal
vein tumor thrombus；multiple hepatocellular carcinoma was allowed to be treated with
surgical excision combined with intraoperative ablation.
- Child-Pugh score: A grade (≤6 points).
- ECOG PS score: 0-1 points.
Exclusion Criteria:
- 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.
- Currently accompanied by interstitial pneumonia or interstitial lung disease.
- Existence of active autoimmune disease or history of autoimmune disease and may
relapse.
- Patients with active infection, unexplained fever ≥38.5℃ within 1 week before
randomization, or baseline white blood cell count >15*10^9/L.
- Patients with congenital or acquired immune deficiencies (such as HIV-infected
persons).
- Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis
targeted drugs or excipients.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuehao Wang
Phone:
86-025-68303211
Email:
wangxh@njmu.edu.cn
Start date:
November 2022
Completion date:
November 1, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05613478
