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

NCT ID: NCT05613478

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2027-11-01

Brief Summary

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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.

Detailed Description

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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, adjuvant therapy (camrelizumab and apatinib, 6 cycles); in the control group, patients will be treated with following: radical surgery,adjuvant therapy (camrelizumab and apatinib, 6 cycles). 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.

Conditions

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Hepatocellular Carcinoma Immunotherapy Preoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Preoperative TACE treatment → preoperative camrelizumab combined with apatinib mesylate (q2w, 2 cycles) → radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles)

Group Type EXPERIMENTAL

Camrelizumab

Intervention Type DRUG

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

Apatinib Mesylate

Intervention Type DRUG

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

Radical surgery

Intervention Type PROCEDURE

Radical surgery

Preoperative TACE treatment

Intervention Type PROCEDURE

TACE treatment before preoperative camrelizumab combined with apatinib mesylate

Control group

Radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles)

Group Type ACTIVE_COMPARATOR

Radical surgery

Intervention Type PROCEDURE

Radical surgery

Camrelizumab

Intervention Type DRUG

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

Apatinib Mesylate

Intervention Type DRUG

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

Interventions

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Camrelizumab

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

Intervention Type DRUG

Apatinib Mesylate

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

Intervention Type DRUG

Radical surgery

Radical surgery

Intervention Type PROCEDURE

Preoperative TACE treatment

TACE treatment before preoperative camrelizumab combined with apatinib mesylate

Intervention Type PROCEDURE

Camrelizumab

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

Intervention Type DRUG

Apatinib Mesylate

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xuehao Wang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuehao Wang, professor

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Yongxiang Xia

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical Univer

Locations

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Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuehao Wang, professor

Role: CONTACT

Phone: 86-025-68303211

Email: [email protected]

Facility Contacts

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Xuehao Wang

Role: primary

Other Identifiers

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2022-SR-558

Identifier Type: -

Identifier Source: org_study_id