A Real-world Study of Camrelizumab Combined With Apatinib Mesylate in Unresectable Hepatocellular Carcinoma

NCT ID: NCT05409482

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-20
• Study Completion Date: 2026-03-01

Brief Summary

To evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the treatment of unresectable hepatocellular carcinoma.

Detailed Description

Combination therapy for patients with unresectable liver cancer is the future trend, and with the development of therapeutic drugs for liver cancer, especially molecular targeted drugs and immunotherapy drugs, the effective rate of liver cancer treatment has been significantly improved, and the treatment of unresectable liver cancer has gradually changed. possible. Therefore, for patients with unresectable liver cancer, how to choose a combined treatment plan will be an important means to improve the therapeutic effect of liver cancer, and it is also a hot spot in the field of clinical research on liver cancer in recent years.

Based on the above research background, this study is now designed as a non-intervention, selecting patients with unresectable hepatocellular carcinoma as the research subjects to analyze the efficacy and safety of camrelizumab combined with apatinib mesylate. In order to bring more long-term benefits to patients with unresectable hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Age: 18 years old ≤ age ≤ 75 years old, both male and female;

2. Strictly meet the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer" (2022 Edition) or hepatocellular carcinoma patients diagnosed by histopathological or cytological examinations , and at least one measurable lesion (according to the mRECIST1.1 standard, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the malignant lymph node is ≥15mm);

3. Not previously accepted Patients with hepatocellular carcinoma who have progressed/intolerable and unresectable after systemic therapy or first-line systemic therapy;

4. CNLC stage IIb-IIIb;

5. Child-Pugh liver function grade A or B (5- 7 points);

6. ECOG PS score 0-1 points;

7. Expected survival period ≥ 12 weeks;

8. If the patient has active hepatitis B virus (HBV) infection: if HBV-DNA ≤ 2000, you can start directly Treatment; if HBV-DNA>2000, antiviral treatment should be given for one week before starting treatment;

9. The subjects volunteered to join the study, had good compliance, and cooperated with follow-up.

Exclusion Criteria

1. Pregnant or breastfeeding women;

2. Patients with contraindications to immunotherapy, including but not limited to the following: post-transplantation patients, patients with severe autoimmune diseases, patients with organ failure, patients who have previously experienced adverse reactions of grade 4 or above using immunotherapy, and uncontrolled infectious diseases;

3. Use immunosuppressive or systemic hormone therapy within 14 days before enrollment to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other equivalent hormones);

4. It has been confirmed that camrelizumab Patients who are allergic to injections, apatinib mesylate tablets and their excipients, or are allergic to other monoclonal antibodies;

5. Patients with impaired consciousness or inability to cooperate with treatment, combined with mental illness;

6. Patients who have participated in other clinical trials in the past three months;

7. Severe liver, kidney, heart, lung, brain and other major organ failure;

8. According to the investigator's judgment, patients with other serious concomitant diseases that endanger the patient's safety or affect the patient's completion of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Meng Chao Hepatobiliary Hospital of Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yongyi Zeng

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wu h Guo

Role: STUDY_DIRECTOR

Mengchao Hepatobiliary Hospital, Fujian Medical University

Zhi bo Zhang

Role: STUDY_DIRECTOR

First Affiliated Hospital of Fujian Medical University

Yi p Chen

Role: STUDY_DIRECTOR

First Affiliated Hospital of Fujian Medical University

Ning Huang

Role: STUDY_DIRECTOR

Union Hospital Affiliated to Fujian Medical University

Mao l Yan

Role: STUDY_DIRECTOR

Fujian Provincial Hospital

Zhu t Fang

Role: STUDY_DIRECTOR

Fujian Provincial Hospital

Hui Zhang

Role: STUDY_DIRECTOR

Fujian Cancer Hospital

Xiao j Zhang

Role: STUDY_DIRECTOR

The 900th Hospital of the Joint Logistics Support Force

Ling q Yan

Role: STUDY_DIRECTOR

Fuqing City Hospital

Yan m Zhou

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Xiamen University

Yong yi Zeng

Role: PRINCIPAL_INVESTIGATOR

Mengchao Hepatobiliary Hospital, Fujian Medical University

Ping g Liu

Role: STUDY_DIRECTOR

Zhongshan Hospital Affiliated to Xiamen University

Fu q Wang

Role: STUDY_CHAIR

Xiamen Hospital of Traditional Chinese Medicine

Bo h Zhang

Role: STUDY_DIRECTOR

Zhongshan Hospital (Xiamen), Fudan University

Cong r Wang

Role: STUDY_DIRECTOR

Quanzhou First Hospital

Wei Wang

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Fujian Medical University

Yu f Chen

Role: STUDY_DIRECTOR

Zhangzhou Hospital

Shao w Zhuang

Role: STUDY_CHAIR

Zhangzhou Hospital

Jian f Zhao

Role: STUDY_DIRECTOR

Affiliated Hospital of Putian University

Jia f Chen

Role: STUDY_DIRECTOR

Putian First Hospital

Wen l Zeng

Role: STUDY_DIRECTOR

Longyan Second Hospital

Yong z Wang

Role: STUDY_DIRECTOR

Sanming Second Hospital

Wen f Wu

Role: STUDY_DIRECTOR

Nanping Second Hospital

Wen x Xie

Role: STUDY_DIRECTOR

Fuding City Hospital

Feng Lin

Role: STUDY_DIRECTOR

Ningde Mindong Hospital

Locations

Mengchao Hepatobiliary Hospital, Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yong yi Zeng

Role: CONTACT

lamp197311@126.com

13805083802

Facility Contacts

Yong yi Zeng

Role: primary

Other Identifiers

22-OBU-FJ-CA-ALL-001

Identifier Type: -

Identifier Source: org_study_id