Cholangiocarcinoma
Conditions
Interventions
Experimental group:Preoperative: Karelizumab 200mg q2w, orally administered with rivatinib once daily for 2-8 cycles. Evaluate the efficacy every 2 cycles, and then perform surgery
Postoperative: Original adjuvant therapy, up to one year
Sponsors
Qingdao University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced gallbladder cancer: (Meet at least one of the following requirements) (1) There are liver metastases, but they are limited to the extent that they can be surgically removed; (2) The primary lesion invades one of the following blood vessels: 1) The main or sciatic branch of the portal vein is invaded and cannot be reconstructed; 2) Inherent hepatic artery or common hepatic artery: invaded > 180 degree; Or invaded = 3 months; 5. Routine laboratory examination (blood routine, liver and kidney function, coagulation function, etc.) no significant abnormality: (1) The blood routine examination standard should meet the requirements of (no blood transfusion and blood preparation within 14 days Product): 1) ANC >= 1.5 x 10^9/L; 2) PLT >= 80 x 10^9//L; (2) Biochemical examination shall meet the following standards: 1) TBIL 45 ml/min(Cockcroft Default formula); 6. Provide intraoperative tissue and blood samples for pathological testing for subsequent scoring Analysis; 7. Patients with potential fertility need to be treated during the research and research Use a medically approved medication within month after the end of the treatment period Pregnancy measures (such as intrauterine devices, birth control pills, or condoms); And needs to be completed in the The serum or urine HCG test must be negative within 72 hours before study enrollment Sex, and must be non lactating; 8. Agde 18-80 years; 9. Subjects voluntarily participate in this study and sign an informed consent form, good compliance, cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. BMI = 10% within 2 months before screening (Also consider the impact of large amounts of ascites on body weight); 2. Abnormal coagulation function (INR > 1.5 APTT > 1.5 ULN) Blood inclined person; Patients with a potential risk of bleeding; 3. Fibrous lamellar hepatocellular carcinoma previously confirmed by histology/cytology Sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, and other components; 4. Have a history of hepatic encephalopathy or liver transplantation; 5. Previous studies on investigational drugs: any component of camrelizumab and levatinib Have a history of allergies; 6. Subjects with refractory pleural, abdominal, or pericardial effusion are poorly controlled; 7. Have a history of interstitial lung disease (excluding radiation without hormone therapy) A history of non infectious pneumonia; 8. The subject has any active autoimmune disease or autoimmune disease Medical history (such as, but not limited to, autoimmune hepatitis, interstitial Sexual pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, Nephritis, hyperthyroidism, decreased thyroid function; Subject Patient Having vitiligo or having complete remission of asthma during childhood, no need to take care of it in adulthood What interventions can be included; Subjects need bronchodilators for medical purposes Interventional asthma cannot be included); 9. Subjects are using immunosuppressants, or systemic or absorbable drugs Partial hormone therapy for immunosuppressive purposes (dose > 10 mg/day) Nisone or other effective hormones), and still in the first 2 weeks before enrollment Continued use; 10. Serious infection (CTCAE) occurred 4 weeks before the first use of the study drug > Level 2), such as severe pneumonia, bacteremia Infection complications, etc; Baseline chest imaging revealed active lung Symptoms of inflammation and infection within 2 weeks before the first use of the study drug And signs or the need for oral and intravenous antibiotic treatment, excluding prevention Sexual use of antibiotics; 11. The subject has experienced acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction within 1 month Congestion, acute coronary syndrome, and other clinical cardiovascular symptoms or diseases Good control; 12. According to NYHA standards, Grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound Left ventricular ejection fraction (LVEF) 140 mmHg or Diastolic pressure > 90 mmHg, history of hypertensive crisis or hypertensive encephalopathy; 14. Patients with a clear propensity for gastrointestinal bleeding include the following: There is a locally active ulcer lesion and stool occult blood {(++) cannot be removed Join group}; Have a history of black stool and hematemesis within 2 months; 15. Wounds or fractures that have not been cured for a long time; Major surgical experience within 4 weeksSevere traumatic injury, fracture, or ulcer may occur during surgery; 16. Subjects with congenital or acquired immune defects (such as HIV infected persons),Or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds Upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA test The measured value exceeds the upper limit of the normal value); 17. Persons who have a history of abuse of psychotropic substances and are unable to abstain or ha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resectionrate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;Major pathological response rate;Progressive free survival;overall survival;Quality of life; | — |
Countries
China
Contacts
Public ContactBing Han
Qingdao University Affiliated Hospital
Outcome results
None listed