HCC
Conditions
Interventions
Test group :CapeOX plus bevacizumab
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily join the study and sign the informed consent form; 2. Age >=18 years old, no gender restriction; 3. Hepatocellular carcinoma is confirmed by pathology; 4. Previous liver transplantation, recurrence and metastasis after operation; 5. Failure or intolerance of at least first-line TKI after liver transplantation; 6. According to the standard of RECIST v1.1, there should be at least one measurable lesion; 7. ECOG PS: 0 or 1; 8. Child-Pugh liver function: =12 weeks; 10. The function of major organs meets the following requirements (within 7 days before enrollment): 1) The blood routine examination must meet the following standards: A.Neutrophils >=1.5×10^9/L, which cannot be achieved by using granulocyte colony stimulating factor; B.The platelet count is >=75×10^9/L, which cannot be achieved by blood transfusion; C.Hemoglobin >=90g/L; 2) Blood biochemistry examination must meet the following criteria: A. Serum albumin >=30g/L; B. The total bilirubin is less than or equal to 2 x ULN (biliary obstruction allows biliary drainage); C. Glutamic transaminase =50 ml/min or serum creatinine is =2+,24-hour urine protein quantification is required, and 24-hour urine protein quantification <1.0g can be included in the group); 11. Patients with active hepatitis B virus infection who begin antiviral therapy during the screening phase and are willing to receive antiviral treatment throughout the study; patients with hepatitis C virus RNA-positive who must receive antiviral treatment according to local standard treatment guidelines and have liver function elevated to CTCAE grade 1 or less; 12. Women of childbearing age: must agree to use reliable contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug; and the serum HCG test must be negative within 7 days before starting the study treatment; and must not be breastfeeding. 13. Male patients with a partner who is a fertile woman must agree to use reliable contraception from the time of signing the informed consent form until at least 120 days after the last dose of the study drug. During the same period, male patients must also agree not to donate sperm.
Exclusion criteria
Exclusion criteria: 1. Known pathological types include intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma, and fibroblastic cell carcinoma; having had other malignant tumors other than hepatocellular carcinoma within the past 5 years or at the same time. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, can be included in the group; 2. Patients with intrahepatic tumor load more than 50%, patients with Vp3 and Vp4 portal thrombosis, and patients with diffuse bone metastasis; 3. Patients who are preparing to undergo or have previously received allogeneic bone marrow transplantation; 4. Patients with a history of hepatic encephalopathy; 5. Moderate or severe ascites with clinical symptoms, that is, those who need therapeutic puncture and drainage or those with an ascites score>2 on Child-Pugh score (except those with minimal ascites on imaging but without clinical symptoms); uncontrolled pleural effusion, pericardial effusion; 6. Patients with a history of gastrointestinal bleeding or a clear tendency to bleed in the gastrointestinal tract within 6 months before the start of treatment, such as: esophageal or gastric varices with bleeding risk, locally active peptic ulcers, or persistent positive fecal occult blood, are not eligible for enrollment (if the fecal occult blood is positive at baseline, a retest is required; if it remains positive after retest, a gastroscopy is needed; if the gastroscopy indicates esophageal or gastric varices with bleeding risk, the patient is not eligible for enrollment); 7. Known hereditary or acquired bleeding (such as coagulation disorders) or thrombophilia, such as hemophilia; currently or recently (within 10 days before the start of the study treatment) using full doses of oral or injectable anticoagulants or thrombolytics for therapeutic purposes (low-dose aspirin or low molecular weight heparin is allowed for prophylaxis); 8. Patients who have had thrombosis or embolism events within 6 months before the start of treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.; 9. Clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure according to the New York Heart Association (NYHA) standard II or higher, or echocardiography showing: LVEF (left ventricular ejection fraction) 450ms (men); QTc> 470ms (women) (QTc interval calculated using the Fridericia formula; if QTc is abnormal, measure three times consecutively with a 2-minute interval, and take the average); 10. Hypertensive patients who fail to achieve good control with antihypertensive medication (systolic blood pressure >=140mmHg or diastolic blood pressure >=90mmHg) (based on the average of BP readings obtained from >=2 measurements), and are allowed to achieve the above parameters through the use of antihypertensive therapy; those with a history of hypertensive crisis or hypertensive encephalopathy; 11. Patients who had intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;time to remission;duration of relief;progression free survival;overall survival; | — |
Countries
China
Contacts
Public ContactMing Yang
Beijing Tsinghua Changgung Hospital
Outcome results
None listed