Clinical trial NCT05409482: A Real-world Study of Camrelizumab Combined With Apatinib Mesylate in Unresectable Hepatocellular Carcinoma
Official title: A Real-world Study of Camrelizumab Combined With Apatinib Mesylate in Unresectable Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: Meng Chao Hepatobiliary Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
First posted: 2022-06-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable hepatocellular carcinoma

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.

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.

Primary outcomes:
measure: Progression-free survival（PFS）
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective response rate（ORR）
timeFrame: Up to 2 years
measure: Disease control rate（DCR）
timeFrame: Up to 2 years
measure: Overall survival（OS）
timeFrame: Up to 8 years
measure: Occurence of AE and SAE
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital, Fujian Medical University
state: Fujian
Study officials:
affiliation: Mengchao Hepatobiliary Hospital, Fujian Medical University
name: Wu h Guo
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Fujian Medical University
name: Zhi bo Zhang
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital of Fujian Medical University
name: Yi p Chen
role: STUDY_DIRECTOR
affiliation: Union Hospital Affiliated to Fujian Medical University
name: Ning Huang
role: STUDY_DIRECTOR
affiliation: Fujian Provincial Hospital
name: Mao l Yan
role: STUDY_DIRECTOR
affiliation: Fujian Provincial Hospital
name: Zhu t Fang
role: STUDY_DIRECTOR
affiliation: Fujian Cancer Hospital
name: Hui Zhang
role: STUDY_DIRECTOR
affiliation: The 900th Hospital of the Joint Logistics Support Force
name: Xiao j Zhang
role: STUDY_DIRECTOR
affiliation: Fuqing City Hospital
name: Ling q Yan
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Xiamen University
name: Yan m Zhou
role: STUDY_DIRECTOR
affiliation: Mengchao Hepatobiliary Hospital, Fujian Medical University
name: Yong yi Zeng
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Hospital Affiliated to Xiamen University
name: Ping g Liu
role: STUDY_DIRECTOR
affiliation: Xiamen Hospital of Traditional Chinese Medicine
name: Fu q Wang
role: STUDY_CHAIR
affiliation: Zhongshan Hospital (Xiamen), Fudan University
name: Bo h Zhang
role: STUDY_DIRECTOR
affiliation: Quanzhou First Hospital
name: Cong r Wang
role: STUDY_DIRECTOR
affiliation: The Second Affiliated Hospital of Fujian Medical University
name: Wei Wang
role: STUDY_DIRECTOR
affiliation: Zhangzhou Hospital
name: Yu f Chen
role: STUDY_DIRECTOR
affiliation: Zhangzhou Hospital
name: Shao w Zhuang
role: STUDY_CHAIR
affiliation: Affiliated Hospital of Putian University
name: Jian f Zhao
role: STUDY_DIRECTOR
affiliation: Putian First Hospital
name: Jia f Chen
role: STUDY_DIRECTOR
affiliation: Longyan Second Hospital
name: Wen l Zeng
role: STUDY_DIRECTOR
affiliation: Sanming Second Hospital
name: Yong z Wang
role: STUDY_DIRECTOR
affiliation: Nanping Second Hospital
name: Wen f Wu
role: STUDY_DIRECTOR
affiliation: Fuding City Hospital
name: Wen x Xie
role: STUDY_DIRECTOR
affiliation: Ningde Mindong Hospital
name: Feng Lin
role: STUDY_DIRECTOR
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