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

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

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Yong yi Zeng; Phone Number: 13805083802; Email: lamp197311@126.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Mengchao Hepatobiliary Hospital, Fujian Medical University
      • Contact: Yong yi Zeng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable hepatocellular carcinoma

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival（PFS）	PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by mRECIST criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate（ORR）	Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to mRECIST 1.1 criteria.	Up to 2 years
Disease control rate（DCR）	Refers to the proportion of all subjects with the best overall response (BOR) according to mRECIST criteria as complete remission (CR), partial remission (PR) and stable disease (SD).	Up to 2 years
Overall survival（OS）	Defined as the time from the date of the first dose to the death of the subject from any cause.	Up to 8 years
Occurence of AE and SAE	Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）	Up to 2 years

Collaborators and Investigators

• Sponsor: Meng Chao Hepatobiliary Hospital of Fujian Medical University
• Collaborators: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Investigators: Study Director: Wu h Guo, Mengchao Hepatobiliary Hospital, Fujian Medical University; Study Director: Zhi bo Zhang, First Affiliated Hospital of Fujian Medical University; Study Director: Yi p Chen, First Affiliated Hospital of Fujian Medical University; Study Director: Ning Huang, Union Hospital Affiliated to Fujian Medical University; Study Director: Mao l Yan, Fujian Provincial Hospital; Study Director: Zhu t Fang, Fujian Provincial Hospital; Study Director: Hui Zhang, Fujian Cancer Hospital; Study Director: Xiao j Zhang, The 900th Hospital of the Joint Logistics Support Force; Study Director: Ling q Yan, Fuqing City Hospital; Study Director: Yan m Zhou, The First Affiliated hospital of Xiamen University; Principal Investigator: Yong yi Zeng, Mengchao Hepatobiliary Hospital, Fujian Medical University; Study Director: Ping g Liu, Zhongshan Hospital Affiliated to Xiamen University; Study Director: Cong r Wang, Quanzhou First Hospital; Study Director: Wei Wang, The Second Affiliated Hospital of Fujian Medical University; Study Director: Yu f Chen, Zhangzhou Hospital; Study Chair: Shao w Zhuang, Zhangzhou Hospital; Study Director: Jian f Zhao, Affiliated Hospital of Putian University; Study Director: Jia f Chen, Putian First Hospital; Study Director: Wen l Zeng, Longyan Second Hospital; Study Director: Yong z Wang, Sanming Second Hospital; Study Director: Wen f Wu, Nanping Second Hospital; Study Director: Wen x Xie, Fuding City Hospital; Study Director: Feng Lin, Ningde Mindong Hospital; Study Director: Bo h Zhang, Zhongshan Hospital (Xiamen), Fudan University; Study Chair: Fu q Wang, Xiamen Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2022
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 22-OBU-FJ-CA-ALL-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No