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

NCT05409482 | Recruiting

• 1 other identifier: 22-OBU-FJ-CA-ALL-001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective response rate（ORR）

  Up to 2 years

• Disease control rate（DCR）

  Up to 2 years

• Overall survival（OS）

  Up to 8 years

• Occurence of AE and SAE

  Up to 2 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable hepatocellular carcinoma

You may qualify if:

• Age: 18 years old ≤ age ≤ 75 years old, both male and female;
• 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);
• Not previously accepted Patients with hepatocellular carcinoma who have progressed/intolerable and unresectable after systemic therapy or first-line systemic therapy;
• CNLC stage IIb-IIIb;
• Child-Pugh liver function grade A or B (5- 7 points);
• ECOG PS score 0-1 points;
• Expected survival period ≥ 12 weeks;
• 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;
• The subjects volunteered to join the study, had good compliance, and cooperated with follow-up.

You may not qualify if:

• Pregnant or breastfeeding women;
• 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;
• 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);
• 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;
• Patients with impaired consciousness or inability to cooperate with treatment, combined with mental illness;
• Patients who have participated in other clinical trials in the past three months;
• Severe liver, kidney, heart, lung, brain and other major organ failure;
• 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.

Sponsors & Collaborators

• Meng Chao Hepatobiliary Hospital of Fujian Medical University: lead
• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: collaborator

Study Sites (1)

Mengchao Hepatobiliary Hospital, Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• 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

  STUDY DIRECTOR

• Yong yi Zeng

  Mengchao Hepatobiliary Hospital, Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Ping g Liu

  Zhongshan Hospital Affiliated to Xiamen University

  STUDY DIRECTOR

• Fu q Wang

  Xiamen Hospital of Traditional Chinese Medicine

  STUDY CHAIR

• Bo h Zhang

  Zhongshan Hospital (Xiamen), Fudan 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 DIRECTOR

• Shao w Zhuang

  Zhangzhou Hospital

  STUDY CHAIR

• 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

Central Study Contacts

Yong yi Zeng

CONTACT

13805083802; lamp197311@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 8, 2022
• Study Start: August 20, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

CN (1)