Hepatocellular carcinoma
Conditions
Interventions
Group 1:Apatinib mesylate tablets, 250 mg once daily, orally
Camrelizumab, 200 mg, intravenous drip, q3w (±3 days), with 3 weeks as one cycle
Radiotherapy, total dose of 50-60 Gy, administered in 25-30 fractions.
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, both male and female; 2. Patients with hepatocellular carcinoma confirmed by imaging or pathological examination; 3.Patients with primary and treatment-naïve disease who are inoperable or have contraindications to surgery due to medical conditions; patients who have relapsed after surgery and are ineligible for further surgery; patients with recurrence or residual disease after RFA/TACE treatment who are also unable to undergo further surgery; patients with or without portal vein tumor thrombus, hepatic vein tumor thrombus, or inferior vena cava tumor thrombus; patients with or without metastasis to the hepatic portal, abdominal, or retroperitoneal lymph nodes; 4. Patients who have not previously received immunotherapy with PD-1 and PD-L1 monoclonal antibodies or molecular targeted therapy with apatinib; 5. Child Pugh score: Grade A or B (= 29g / L; 6. Patients with PS score of 0-1 within one week before enrollment; 7. Patients with measurable lesions in accordance with mRECIST and RECIST1.1 standard; 8. Hematological examination showed that Hb >= 90g / L, ANC >= 1.5*10^9 / L, PLT >= 75 * 10^9 / L, WBC >= 3.0 * 10^9 / L, creatinine <= 1.5 * ULN; 9. Patients with active hepatitis B virus (HBV) infection: HBV DNA must be < 2000 IU / ml (if the research center has only copy / ml detection unit, it must be < 104 copy/mL; and patients must have received at least 14 days of anti-HBV treatment before the start of the study treatment; patients with hepatitis C virus (HCV) RNA positive must have HCV < 103 copy/mL; 10. Women of childbearing age (generally 15-49 years old) should have pregnancy test (serum or urine) negative within 14 days before enrollment, and voluntarily use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of the study drug; male patients must be surgically sterile or agree to use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of the study drug; 11. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. ECOG score >= 2; 2. Bone marrow function not meeting the inclusion criteria; 3. Patients with history of bleeding from esophageal and gastric varices, hepatic encephalopathy, massive ascites, or abdominal infection; 4. Patients with extrahepatic metastases such as lung, bone, mediastinal lymph nodes, and pelvic lymph nodes; 5. The tumor is close to the intestines and other organs, and patients are difficult to tolerate radiotherapy; the residual liver volume is less than 700 ml, and patients are difficult to tolerate radiation; 6. Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or those planning to undergo transplantation; 7. Previous use of immunosuppressive drugs within 14 days before the first use of Camrelizumab, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (ie: not more than 10 mg/day prednisone or other corticosteroids in equivalent physiological doses); 8. Being allergic to Apatinib, Camrelizumab; or being allergic to other monoclonal antibodies; 9. Being injected with attenuated live vaccine within 4 weeks before the first administration or is planning to inject with attenuated live vaccine during the study; 10. Peripheral neuropathy> Grade 1; 11. There is any active autoimmune disease or a history of autoimmune disease; 12. There is any other malignant tumor history, except for basal cell carcinoma, cutaneous squamous cell carcinoma or cervical carcinoma in situ; 13. Human immunodeficiency virus (HIV) infection or diagonised acquired immunodeficiency syndrome (AIDS); 14. Within 6 months before enrollment, the following conditions occurred: myocardial infarction, severe/unstable angina, >= NYHA Grade 2 cardiac insufficiency, poorly controlled arrhythmia, symptomatic congestive heart failure. 15. Hypertension, which cannot be well controlled by antihypertensive drugs (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 16. Abnormal blood coagulation function (INR>1.5 or APTT>1.5*ULN), bleeding tendency or undergoing thrombolysis treatment, anticoagulation therapy or antiplatelet therapy, etc.; 17. Known to have inherited or acquired bleeding and thrombotic tendency, such as: hemophilia, blood coagulation dysfunction, thrombocytopenia, hypersplenism, etc.; 18. Daily hemoptysis amounting to half a teaspoon (2.5 ml) within 2 months before enrollment; 19. Patients at risk of gastrointestinal bleeding, including the following: (1) With active peptic ulcer lesions; (2) Those who have a history of melena and hematemesis within 3 months; (3) For stool occult blood (+) or (+/-), it is necessary to review the stool routine within 1 week, Patients still (+) or (+/-) must undergo gastroscopy, if there are ulcers, bleeding disorders, and the physician believes that there is a potential risk of bleeding; 20. Arterial/venous thrombotic events that occurred within 6 months before entering the study, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; 21. Infections requiring drug intervention (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or unexplained fever > 38.5 degrees Celsius during the screening period or before the first administration; 22. Participated in any other drug clinical research within 4 weeks be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;overall response rate, ORR;Disease Control Rate, DCR;Advers Events;Objective Response Rate, ORR;Disease Control Rate, DCR;progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactWang Weihu
Beijing Cancer Hospital
Outcome results
None listed