NCT04521153Active, not recruitingPhase 2/3
Camrelizumab Combined With Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma
Camrelizumab Combined With Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma：a Randomized, Open-label, Parallel, Multicenter Trial
Source: ClinicalTrials.gov · Last updated 11 May 2025
Brief summary (registry, in English)
Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%\~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma.The primary purpose of this study is to evaluate the rate of subjects with major pathological response for phase 2 study and event-free survival (EFS) by investigator for phase 3 study of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate EFS by Blinded Independent Review Committee, the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, overall survival and disease-free survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 294 (actual)
- First submitted
- 18 Aug 2020
- Start date
- 25 Mar 2021
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04521153
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 294
- From 25 Mar 2021 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time.
- Currently accompanied by interstitial pneumonia or interstitial lung disease
- Existence of active autoimmune disease or history of autoimmune disease and may relapse
- Patients with congenital or acquired immune deficiencies (such as HIV-infected persons)
- Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients
Lab values
- Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count \>15\*10\^9/L
Who the study is looking for
- Volunteer to participate in this study and sign an informed consent form
- Age 18\~75 years old, no gender limit
- Hepatocellular carcinoma confirmed by histopathology, cytology or imaging
- CNLC stage Ib/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus
- Child-Pugh score: A grade (≤6 points)
- ECOG PS score: 0-1 points
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 180 Fenglin Road Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.