First-line targeted therapy failure in oligometastatic hepatocellular carcinoma
Conditions
Interventions
Experimental Group:Stereotactic Body Radiation Therapy(SBRT)+Aronitin+Bemsimab
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily participated in the study, signed the informed consent form, and the compliance was good. 2. Age >=18 years old, male or female; 3. Patients with histologically confirmed or clinically diagnosed HCC, and the disease is not suitable for radical surgery; 4. Patients with oligometastatic HCC who had failed previous target-immunotherapy combined with first-line therapy. Oligometastases are defined as the number of metastatic organs =2 and the total number of metastases =12 weeks; 8. At least one measurable lesion (the long diameter of the measurable lesion on enhanced spiral CT or enhanced MR Scan >=10mm or the short diameter of the enlarged lymph node >=15mm according to RECISTv1.1; a lesion that has been treated with previous radiotherapy can be considered as a target lesion after definite progression according to RECISTv1.1 criteria); 9. The following laboratory tests performed within 7 days before the first dose of medication confirmed that the patient's bone marrow, liver and kidney function met the following requirements for study participation: 1) hemoglobin >=80 g/L (which can be maintained or exceeded by transfusion); 2) absolute neutrophil count (ANC) >=1.5×10^9; 3) platelet count >=50×10^9/mm3; 4) Total bilirubin =60ml/min; 7) international normalized ratio (INR) of prothrombin time =12 months of continuous absence of menses, with no cause other than menopause identified), and had not undergone sterilization procedures (e.g., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). 11. Male patients whose partner was a woman of reproductive age had to agree to abstain from sex or to use a reliable, effective method of contraception for at least 120 days from the time of written informed consent until the last dose of study drug was administered. Male patients also had to agree not to donate sperm during the same period. Male subjects whose partner was pregnant were required to use condoms.
Exclusion criteria
Exclusion criteria: 1. Known cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrolamellar cell carcinoma. Other active malignant tumors other than HCC within 5 years or at the same time. The cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc., were excluded. 2. Prior receipt of anlotinib or a non-PD-1 monoclonal antibody immune checkpoint inhibitor; 3. The time interval between the last target-free drug use and enrollment was less than 3 weeks. 4. Patients who received previous local treatment (including TACE, ablation, HAIC, or radiotherapy) for the target lesion less than 1 month before enrollment. 5. Patients preparing for or previously receiving organ or allogeneic bone marrow transplantation; 6. Moderate or severe ascites with clinical symptoms, which required therapeutic puncture, drainage or Child-Pugh score >2 (except for patients with small amount of ascites on imaging but without clinical symptoms); Uncontrolled or moderate or above amount of pleural effusion and pericardial effusion; 7. A history of gastrointestinal bleeding within 6 months before the initiation of study treatment or a definite tendency for gastrointestinal bleeding, such as: Patients with risk of bleeding or severe esophagogastric varices, local active gastrointestinal ulcer lesions, and persistent positive fecal occult blood were excluded (patients with positive fecal occult blood at baseline could be re-examined, and patients with positive fecal occult blood after re-examination required gastroduodenoscopy (EGD). Patients with esophagogastric varices with a risk of bleeding were excluded). 8. Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before study treatment; 9. Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in hemophilia patients; 10. Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin was allowed); 11. Currently using or recently using (within 10 days before initiation of study treatment) aspirin (> 325 mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol; Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment; 12. There are not well controlled cardiac clinical symptoms or diseases, such as: (1) according to the New York Heart Association (NYHA) criteria (see Annex 5) grade II or higher cardiac dysfunction or cardiac ultrasound examination: Left ventricular ejection fraction (LVEF) 450ms (male); QTc > 470ms (female) (QTc interval was calculated with Fridericia's formula; if QTc was abnormal, three consecutive tests could be performed at a 2-minute interval, and the mean value was calculated); 13. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure =90 mm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median survival time;Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival (OS);Time to progression (TTP);Time to local progression (TTLP);Duration of Response (DoR); | — |
Countries
China
Contacts
Public ContactJinzhang Chen
Southern Medical University Southern Hospital
Outcome results
None listed