Hepatocellular carcinoma
Conditions
Interventions
Adjuvant HFRT combined with PD-1 group:4-6 weeks post-surgery, patients begin treatment with PD-1 monoclonal antibody (Sintilimab 200mg, intravenous infusion, once every 21 days, for a total of 10 cyc
Control group: Follow-up is done routinely.
Sponsors
Eastern hepatobiliary surgery hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients voluntarily join this study and sign the informed consent form. Age between 20 and 75 years old, regardless of gender. Radical hepatectomy for liver cancer performed within one month prior to enrollment, with postoperative pathology confirming hepatocellular carcinoma. Patients must also exhibit one or more of the following features: tumor maximum diameter greater than 5cm, presence of 2-3 tumors, presence of microvascular invasion (MVI), tumor boundary to resection margin less than 1cm. Liver function with a Child-Pugh score of 2000 copies/ml, antiviral medication should be started orally at least 1 week prior. For non-surgically sterilized or fertile women, they need to use one medically approved contraceptive method during the study treatment and for 3 months after the end of treatment (e.g., intrauterine device, birth control pills or condoms). Non-surgically sterilized fertile women must have a negative serum or urine HCG test within 72 hours before enrollment and must not be breastfeeding.
Exclusion criteria
Exclusion criteria: Patients who have undergone radiation, systemic treatments such as targeted or immunotherapy regimens in the past 3 months. Patients who have undergone palliative resection for liver cancer, or those with lymph node metastasis or distant organ metastasis. Patients with clinically symptomatic ascites requiring puncture or continuous drainage, excluding those with only radiographic evidence of minimal ascites without clinical symptoms. Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) Heart failure of grade 2 or above, unstable angina; (2) Myocardial infarction that occurred within the past year; (3) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (4) Severe hyperthyroidism or hypothyroidism. Abnormal coagulation (INR > 2.0, PT > 16s), a propensity to bleed or currently receiving thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin, low molecular weight heparin, etc., is allowed. Significant clinically meaningful bleeding events within the 3 months prior to randomization (excluding surgical wound bleeding) or a clear propensity to bleed, such as gastrointestinal bleeding, esophageal and gastric varices with a bleeding risk, hemorrhagic gastric ulcers, or vasculitis. If the occult blood test during the baseline period is positive, it requires re-examination. If it remains positive, gastroscopy and colonoscopy are required. If the gastroscopy indicates severe esophageal and gastric varices with red signs, the patient cannot be enrolled. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, etc.). Urinalysis indicating proteinuria =++ and confirmed 24-hour proteinuria > 1.0g. Adverse events from previous surgeries and other treatments not recovered to = CTCAE grade 1. Patients with active infections, unexplained fever =38.5°C within 7 days prior to medication, or a baseline white blood cell count of =15*10^9/l. HIV or syphilis infection. Patients with another malignancy within the past 3 years or concurrently. Patients with chronic headaches or migraines that medication cannot relieve. Patients deemed unsuitable to participate in the trial for other reasons as judged by the researcher, such as severe mental illness, drug abuse, or family or social factors making enrollment inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Adverse events of RT and PD-1; | — |
Countries
China
Contacts
Public ContactShuqun Cheng
Eastern hepatobiliary surgery hospital
Outcome results
None listed