Hepatocellular carcinoma
Conditions
Interventions
adjuvant PD-1 monoclonal antibody combined with capecitabine:Start using PD-1 monoclonal antibody (Tislelizumab 200 mg, intravenous infusion, once every 21 days, for a total of 8 cycles) 4-6 weeks pos
adjuvant capecitabine:Begin oral administration of capecitabine 4-6 weeks post-surgery, at a dose of 1250 mg/m2, twice daily, use for 14 days followed by a 7-day rest, with 21 days as one cycle, for a
Sponsors
Eastern hepatobiliary surgery hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients voluntarily participate in this study and sign an informed consent form; Aged between 20 and 75 years, gender not specified; Underwent curative BTC resection surgery within 4 weeks prior to enrollment, with postoperative pathological diagnosis confirming cholangiocarcinoma (including intrahepatic cholangiocellular carcinoma, extrahepatic cholangiocarcinoma, muscle-invasive gallbladder cancer), regardless of whether the pathological surgical margins are positive and whether there is lymph node metastasis; Liver function Child-Pugh score = 7 points, ALBI grade 1-2; ECOG score: 0-1; Expected survival period =12 weeks; Important organ functions must meet the following requirements (no use of any blood components such as albumin, cell growth factors, or other corrective treatments within 14 days prior to initial treatment): Hemoglobin =90g/L Neutrophil count =1.5×10^9/L Platelet count =60×10^9/L Serum albumin =30g/L Total bilirubin =1.5*ULN (7 days before initial treatment) ALT and AST =3*ULN (7 days before initial treatment) ALP =2.5*ULN Serum creatinine =1.5*ULN Hepatitis B infection status: HBV-DNA 2000 copies/ml, start oral antiviral drugs at least one week before the beginning of the study; Non-surgically sterilized or fertile female patients must use a medically approved contraceptive method (such as an intrauterine device, contraceptive pills, or condoms) during the study treatment period and for three months after the end of treatment; non-surgically sterilized fertile female patients must have a negative serum or urine HCG test within 72 hours before enrollment in the study; and must not be breastfeeding.
Exclusion criteria
Exclusion criteria: Translation: Patients who have received radiation therapy or systemic treatments such as targeted or immunotherapy within the past three months; Patients who have undergone palliative resection or have distant organ metastasis; Patients with clinically symptomatic ascites requiring puncture or continuous drainage, except those who only show a small amount of ascites on imaging without clinical symptoms; Patients with uncontrolled cardiac clinical symptoms or diseases, such as: (1) Class 2 or higher heart failure, unstable angina; (2) Myocardial infarction occurred within the past year; (3) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (4) Patients with severe hyperthyroidism or hypothyroidism; Abnormal coagulation function (INR > 2.0, PT > 16s), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy, preventive use of low-dose aspirin, low molecular weight heparin, etc. is allowed; Significant clinically significant bleeding symptoms (excluding surgical wound bleeding) or a clear bleeding tendency, such as gastrointestinal bleeding, esophageal gastric varices with bleeding risk, hemorrhagic gastric ulcers or vasculitis within three months prior to randomization, baseline positive fecal occult blood tests need rechecking, and if still positive, gastroscopy and colonoscopy are required. If gastroscopy indicates severe esophageal gastric varices with red signs, the patient cannot be included; Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.); Urinalysis indicating proteinuria =++ and confirmed 24-hour urinary protein >1.0g; Patients whose adverse events caused by previous surgery or other treatments have not recovered to = CTCAE Grade 1; Patients with active infections, unexplained fever =38.5°C within 7 days before medication, or baseline white blood cell count =15×10^9/L; HIV or syphilis infection; Patients who have had other malignant tumors within the past three years or concurrently; Patients with chronic headaches or migraines that cannot be relieved by medication; Other reasons deemed by the researcher as inappropriate for participation in the trial, such as severe mental illness, drug abuse, or unsuitable family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence free survival;Time to recurrence;Adverse events of chemotherapy and PD-1; | — |
Countries
China
Contacts
Public ContactShuqun Cheng
Eastern Hepatobiliary surgery hospital
Outcome results
None listed