Hepatic Carcinoma
Conditions
Interventions
Camrelizumab group:Camrelizumab Plus Apatinib
Chemotherapy group:Fluorouracil combined with oxaliplatin chemotherapy
Sponsors
Shengjing Hospital Affiliated to China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient must sign the informed consent and be willing and able to comply with the visit, treatment plan, laboratory examination and other requirements of the study schedule; 2. Age: 18-75 years old, including 18 years old and 75 years old (calculated from the date of signing informed consent), both male and female; 3. Patients with IIB IIIA stage hepatocellular carcinoma or intrahepatic cholangiocarcinoma; 4. The study only included patients who were newly diagnosed and could not be resected, which was evaluated by a team of gastroenterologists, oncologists, interventional radiologists and liver surgery; the definition of unresectable hepatobiliary carcinoma was that the liver was widely bilobar, with single huge tumor or multiple tumor invasion, or the tumor invaded the main portal vein, hepatic vein, inferior vena cava, main hepatic artery and liver Internal bile duct; 5. Patients without extrahepatic metastasis; 6. Patients with child Pugh grade A / better grade B of liver function; 7. Patients who have not received anti-tumor treatment for liver cancer in the past, including chemotherapy and local treatment; 8. The patients whose ECoG score (PS score) = 1.5 * 10^9 / L; platelets >= 100 * 10^9 / L; hemoglobin >= 9 g / dl; serum albumin >= 2.8 g / dl; (2) Thyroid stimulating hormone (TSH) <= 1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be included in the group); (3) Bilirubin <= 1.5 times ULN, ALT and AST <= 3 times ULN; (4) Serum creatinine <=1.5 times ULN. 10. Female patients of non-surgical sterilization or childbearing age need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period; the serum or urine HCG test of non-surgical sterilization women of childbearing age must be negative within 72 hours before the study enrollment; and they must be non lactating period; and For male, it is necessary to perform surgical sterilization or agree to use appropriate contraceptive methods during the trial period and within 3 months after the last administration of the trial drug.
Exclusion criteria
Exclusion criteria: 1. Patients with complications that need to be treated, such as ascites or pleural effusion with clinical symptoms, need therapeutic puncture or drainage; or the unresected tumor has active bleeding; 2. Patients who have suffered from other malignant tumors before or at the same time are excluded from those who have received adequate treatment for non melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma; 3. Patients with active hepatitis B or C (hepatitis B: HBsAg positive and HBV-DNA >= 10 copies / ml; hepatitis C: positive for HCV antibody and HCV-RNA, requiring antiviral treatment at the same time); 4. Patients with active tuberculosis infection. Patients with active tuberculosis infection within one year before medication should be excluded even if they have been treated; patients with active tuberculosis infection history more than one year should also be excluded, unless it is proved that they have received standard anti tuberculosis treatment before. 5. Patients with active, known or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism who received hormone replacement therapy only and skin diseases (such as vitiligo, psoriasis or alopecia) without systemic treatment could be enrolled; 6. Patients with previous interstitial lung disease or (non infectious) pneumonia need oral or intravenous steroid therapy. 7. Patients who need long-term systemic hormone therapy (dose equivalent to more than 10 mg prednisone / day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids could be enrolled; 8. Patients with poorly controlled heart disease, such as: (1) NYHA grade 2 and above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular or ventricular arrhythmias with clinical significance and need treatment or intervention. 9. Patients with hypertension who cannot be well controlled by antihypertensive drugs (SBP >= 140 mmHg or DBP >= 90 mmHg); 10. Patients with abnormal coagulation function (PT > 16S, APTT > 43S, TT > 21s, FBG < 2G / L) had bleeding tendency or were receiving thrombolytic or anticoagulant therapy; 11. In the first 3 months, there were significant bleeding symptoms or bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + or above, or vasculitis; 12. The subjects were known to have been allergic to macromolecular protein preparations or to any component of carrizumab; 13. Patients with active infection who need systemic treatment; 14. Patients with HIV, HIV 1 / 2 antibody positive; 15. Patients who have received or will be vaccinated with live vaccine within 30 days before the administration of carrizumab; 16. Patients with a history of psychotropic substance abuse, alcoholism or drug abuse; 17. Patients with other factors that may affect the safety or compliance of the test determined by the researcher. For example, serious diseases (including mental diseases), serious laboratory abnormalities, or other family or social factors that need to be treated together.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| MPR;DFS;OS;Safety; | — |
Countries
China
Contacts
Public ContactChaoliu Dai, Wei Zheng
Shengjing Hospital Affiliated to China Medical University
Outcome results
None listed