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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05409482
• Other study ID #: 22-OBU-FJ-CA-ALL-001
• Status: Recruiting
• Start date: August 20, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2023
• Source: Meng Chao Hepatobiliary Hospital of Fujian Medical University
• Contact: Yong yi Zeng
• Phone: 13805083802
• Email: lamp197311[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	Mengchao Hepatobiliary Hospital, Fujian Medical University	Fuzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
Meng Chao Hepatobiliary Hospital of Fujian Medical University	Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Occurence of AE and SAE	Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) (NCI CTCAE 5.0)	Up to 2 years