Cancer of the liver
Conditions
Interventions
experimental group:Tirelizumab injection combined with antinib hydrochloride capsule
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who volunteered to join the study signed the informed consent with good compliance and cooperated with the follow-up; 2. Male or female patients aged 18-75 years; 3. Patients with unresectable advanced hepatocellular carcinoma diagnosed by histopathology or cytology, with child = 1.0 cm; (2) The lesions were suitable for repeated measurement; (3) The lesions showed enhancement of intratumoral arteries on computed tomography (CT) or magnetic resonance imaging (MRI). Non hepatic lesions (1) In at least one dimension, the short axis of lymph node lesions (LN) was greater than or equal to 1.5cm, except for hilar ln with short axis greater than or equal to 2.0cm; (2) Non nodular lesions with the longest diameter >= 1.0cm. 5. ECoG score: 0-1; 6. HCC patients who have not received systematic treatment in the past; 7. Patients with an estimated survival time of 12 weeks or more; 8. Subjects with chronic HBV infection must have HBV-DNA = 90g / L (no blood transfusion within 2 weeks); (2) Absolute neutrophil count (ANC) >= 1.5 x 10^9 / L; (3) PLT >= 75 x 10^12 / L Biochemical tests should meet the following standards: (1) Serum bilirubin (TBIL) = 50ml / min, creatinine clearance rate was based on Cockcroft Gault's estimation, formula: x = [(140 age) x body weight (kg) x female 0.85] / [0.818 x serum creatinine (umol / L)]; Female subjects of childbearing age must conduct serum or urine pregnancy test within 14 days before the start of study medication, and the result is negative, and they are willing to use effective or reliable contraceptive methods during the trial period and 60 days after the last administration of trial medication. For male subjects whose partner is a woman of childbearing age, surgical sterilization should be adopted, or an effective or reliable contraceptive method should be adopted during the trial period and 120 days after the last administration of the trial drug.
Exclusion criteria
Exclusion criteria: 1. Patients who have received any systemic treatment, including chemotherapy, targeted and immunotherapy or trial subjects, or patients who have received any systemic research anticancer drugs (including traditional Chinese medicine anticancer drugs) for advanced / unresectable HCC. 2. Patients who have received local treatment for liver (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) or any blood transfusion, blood products and stimulating blood cell growth, such as granulocyte colony-stimulating factor (G-CSF) within 4 weeks before participating in this study; 3. Patients who received other trial drugs or participated in clinical studies for other treatment purposes within 28 days before randomization; 4. Patients with known fibrolamellar cell carcinoma and cholangiocarcinoma; 5. Patients with any severe and / or uncontrolled diseases or symptoms, including: (1) In the past (within 5 years) or at the same time with other incurable malignant tumors. Except for the local tumor which has been cured; (2) Any history of active autoimmune disease or autoimmune disease or suspected autoimmune disease, including HIV positive, preparation or previous organ transplantation history;; (3) Abnormal coagulation function (INR > 1.5 or PT > ULN + 4 seconds or APTT > 1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; long term antiplatelet therapy (aspirin >= 300 mg / day, clopidogrel >= 75 mg / day) Note: under the premise of prothrombin time international normalized ratio (INR) = 450ms for male and >= 470ms for female) (QTc interval was calculated by fridericia formula); according to NYHA standard, patients with grade II or above cardiac insufficiency or cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) 140mmHg, diastolic blood pressure > 90mmHg); (6) Uncontrolled pleural effusion, pericardial effusion, or moderate or more ascites; (7) Urine routine showed that urine protein was more than 2 + and 24-hour urine protein was more than 1.0 G; (8) Active or uncontrollable severe infection, fever of unknown origin (body temperature > 38.5 degrees C) occurred before the first administration; (9) Poor control of diabetes mellitus (FBG > 10mmol / L); 6. Patients with central nervous system metastasis at present or in the past; 7. Patients with a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding within 6 months; abdominal fistula, gastrointestinal perforation or abdominal abscess within 2 months before participating in this study; 8. Patients with known hereditary or acquired bleeding and thrombotic tendency; thromboembolic events occurred in the past 6 months; 9. The patients who can't swallow, chronic diarrhea or intestinal obstruction obviously affect the drug taking and absorption; 10. Patients who received any vaccine treatment within 30 days before enrollment (including anti infecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;DOR; | — |
Countries
China
Contacts
Public ContactZeng Zhiming
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed