Inoperable advanced liver cancer
Conditions
Interventions
Experimental group :radiotherapy combined with immune drugs and targeted drugs
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, regardless of gender. 2. Patients with hepatocellular carcinoma diagnosed by imaging or pathological examination. 3. Those who are initially inoperable, those who relapse after surgery and cannot be operated again, and those who relapse or remain after RFA/TACE treatment and cannot be operated again. 4. The estimated survival period is >= 3 months. 5. Child-Pugh score: Grade A or better grade B (= 29g/L. 6. ECOG score: 0-2 points. 7. There are measurable lesions that meet mRECIST standards. 8. Hematology examination conforms to: HB >= 90g/L, ANC >= 1.5 x 10^9/L, PLT >= 75 x 10^9/L, WBC >= 3.0 x 10^9/L. 9. Patients with hepatitis B and C virus infections should have effective antiviral treatment, HBV DNA < 100IU/ml, HCV DNA < 100IU/ml. 10. Agree to join the group, willing to cooperate with clinical research, and sign an informed consent form. 11. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1. A history of bleeding from esophageal and gastric varices, hepatic encephalopathy, massive ascites, or abdominal infection. 2. The tumor is close to the intestine and other endangered organs, and it is difficult to tolerate radiotherapy; the residual liver volume is less than 700ml, and it is difficult to tolerate radiotherapy. 3. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation. 4. Previously used immunosuppressive drugs within 14 days before the use of immunotherapy, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (ie not more than 10 mg/day prednisolone or equivalent drugs). Doses of other corticosteroids). 5. Known severe allergic reactions to immune or targeted drugs. 6. Vaccine live attenuated vaccine within 4 weeks before the first administration or planned during the study period. 7. Peripheral neuropathy> Grade 1 exists. 8. There is any active autoimmune disease or a history of autoimmune disease. 9. Has been diagnosed with any other malignant tumor, except for fully treated basal cell or squamous cell skin cancer or cervical carcinoma in situ. 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome. 11. Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg). 12. Abnormal blood coagulation function (APTT > 1.5 x ULN), bleeding tendency or receiving thrombolytic therapy, anticoagulation therapy or antiplatelet therapy, etc. 13. Known to have inherited or acquired bleeding and thrombotic tendency, such as: hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc. 14. Those who had obvious coughing up blood 2 months before entering the study. 15. Patients at risk of gastrointestinal bleeding, including the following: (1) There are active peptic ulcer lesions; (2) Those who have a history of melena and hematemesis within 3 months; (3) For fecal occult blood (+) or (+/-), it is necessary to review the stool routine within 1 week. Those who still (+) or (+/-) must undergo gastroscopy. If there is ulcer, bleeding disease, and The treating physician believes that there is a potential risk of bleeding. 16. Arterial/venous thrombosis events that occurred within 6 months before entering the study, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism. 17. Complicated infections requiring drug intervention within 4 weeks before the first administration (for example: intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5°C during screening/before the first administration. 18. Participated in any other drug clinical research within 4 weeks before the first administration. 19. Known history of psychotropic drug abuse or drug abuse. 20. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher believes are not suitable for participating in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;OS;ORR; | — |
Countries
China
Contacts
Public ContactYunwei Han
Affiliated Hospital of Southwest Medical University
Outcome results
None listed