hepatocellular carcinoma
Conditions
Interventions
Experimental group:Preoperative carrelizumab combined with apatinib mesylate (2 treatment cycles) ? radical surgery ? postoperative TACE treatment ? sequential apatinib mesylate combined with carreliz
Control group:Radical surgery?postoperative TACE treatment
Sponsors
Fudan university Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in this study and sign an informed consent form; 2. Aged >=18 years old; 3. Hepatocellular carcinoma confirmed by histopathology, cytology or imaging; 4. CNLC stage IIa/IIb (BCLC stage B) hepatocellular carcinoma patients; 5. Have not received anti-tumor therapy (such as surgery, radiotherapy, TACE, ablation, chemotherapy, targeted therapy, immunotherapy, etc.); 6. Child-Pugh liver function rating: grade A or B (=12 weeks; 9. The laboratory test values within 1 week before randomization meet the following requirements: Routine blood examination: (except for hemoglobin, no blood transfusion, no use of granulocyte colony stimulating factor [G-CSF], no correction with no medication within 2 weeks before screening): Absolute neutrophil count >=1.5x10^9/L; Platelets >=80x10^9/L; Hemoglobin =90 g/L; Biochemical inspection: Serum albumin >=35 g/L; Serum total bilirubin50 ml/min (The Cockcroft-Gault formula is as follows): Male: Cr clearance rate=((140-age)*weight)/(72 blood Cr) Female: Cr clearance rate=((140-age)x weight)/(72 x blood Cr) x 0.85 Weight unit: kg; blood Cr unit: mg/ml; International normalized ratio (INR) =12 months, no other reasons are found except menopause), and have not undergone sterilization (such as hysterectomy, bilateral tubal ligation or Bilateral oophorectomy), the patient is considered to be fertile; 12. For male subjects whose partner is a fertile female, they must agree to abstain from sex for at least 120 days after signing the informed consent form until the last administration of the study drug, or use reliable and effective methods of contraception. Male subjects must also agree not to donate sperm during the same time period. Male subjects whose partners are pregnant must use condoms and no other contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. 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. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in the group; 2. Currently accompanied by interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease that requires hormone therapy, or other pulmonary fibrosis that may interfere with the judgment and management of immune-related lung toxicity, Organizing pneumonia (for example, bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or evidence of active pneumonia or severely impaired lung function on the chest computed tomography (CT) during the screening period Those who are allowed to have radiation pneumonia in the radiation field: active tuberculosis; 3. Existence of active autoimmune disease or history of autoimmune disease and may relapse (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, thyroid function Hyperthyroidism, decreased thyroid function [only subjects that can be controlled by hormone replacement therapy can be included]): Subjects have skin diseases that do not require systemic treatment such as spontaneous epilepsy, psoriasis, hair loss, and are controlled by insulin therapy Type I diabetes or asthma in childhood has been completely relieved, and those without any intervention after adulthood can be included: asthma patients who require medical intervention with bronchodilators cannot be included; 4. Use immunosuppressant or systemic hormone therapy within 2 weeks before randomization to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones); 5. Patients with active infection, unexplained fever >=38.5 degree C within 1 week before randomization, or baseline white blood cell count >15*10^9/L: Oral or intravenous therapeutic antibiotics (receiving prophylactic antibiotics) within 2 weeks before randomization (For example, patients who prevent urinary tract infections or exacerbations of chronic obstructive pulmonary disease are eligible to participate in the study); 6. Patients with congenital or acquired immune deficiencies (such as HIV-infected persons); 7. Received treatment with live attenuated vaccines within 4 weeks before randomization, or expect to receive such vaccines during carrelizumab treatment or within 60 days after the last dose of carrelizumab; 8. There is a history of gastrointestinal bleeding or a clear gastrointestinal bleeding tendency within 6 months before randomization, such as: bleeding risk or severe esophagus and gastric varices, local active gastrointestinal ulcers, persistent fecal occult blood Positives cannot be included in the group (If the stool occult blood is positive at baseline, you can review it. If it is still positive after the review, you need to undergo a gastroduodenal endoscopy (EGD). If EGD indicates bleeding risk of esophageal and gastric varices, you can't enter the group); 9. Known genetic or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency, such as hemophilia patients: currently receiving full-dose oral o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathologic response (MPR);3 year event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overal survival;Disease-free rate;morbidity; | — |
Countries
China
Contacts
Public ContactJian Zhou
Fudan university Zhongshan Hospital
Outcome results
None listed