biliary malignancies
Conditions
Interventions
Treatment group:Carrelizumab and Apatinib in combination with gemcitabine and oxaliplatin
Sponsors
The Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to enter the study: 1) The patients voluntarily joined the study and signed the informed consent; 2) =18 years of age (calculated on the date of signing the informed consent), both male and female; 3) Patients with cholangiocarcinoma confirmed by histopathology or cytology, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma; 4) Subjects must be able to provide fresh or archived tumor tissue (formalin-fixed, paraffin-embedded [FFPE] tissue blocks or at least 5 unstained FFPE slides) and pathology reports. If the subject can provide fewer than 5 unstained slides or the tumor tissue is not available (for example, exhaustion due to previous diagnostic tests), enrollment may be allowed on a case-by-case basis after discussion; 5) The subject is not suitable for surgery, or progresses after surgery and/or local treatment; 6) In patients who progress after local therapy, local therapy (including but not limited to surgery, radiotherapy, arterial embolization, arterial perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) has been completed at least 4 weeks before baseline imaging scans, and the toxic effects (except hair loss) caused by local therapy must be restored to the National Cancer Institute - Standard for General Terminology for Adverse Events Version 5.0 (NCI-CTCAE v5.0) rating =1; 7) Have not received any previous systemic therapy for BTC 8) At least one measurable lesion (as required by RECIST v1.1, a spiral CT scan of a measurable lesion =10 mm in length or an enlarged lymph node =15 mm in diameter) 9) The physical status score of the Eastern Cancer Collaboration Group (ECOG) was 0 to 1 points (see Annex 1 for the ECOG score standard); 10) Expected survival = 12 weeks; 11) The function of major organs is basically normal, and there are no serious functional abnormalities and immune deficiency diseases of blood, heart, lung, liver, kidney, bone marrow, etc., which meet the requirements of the program: a) Routine blood tests: (excluding hemoglobin, no transfusion within 14 days prior to screening, no use of granulocyte colony-stimulating factor [G-CSF], no use of corrective therapy within 7 days) i. Hemoglobin = 90 g/L; ii. Neutrophil count = 1.5×10^9/L; iii. Platelet count = 50×10^9/L; b) Biochemical examination: (no albumin infusion within 14 days) i. Serum albumin = 29 g/L; ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times the upper limit of normal (ULN); iii. Total bilirubin (TBIL) = 1.5 times ULN; iv. Creatinine Cr = 1.5 times ULN or Cr clearance > 50 mL/min (Cockcroft-Gault formula is as follows) Male: Cr clearance =((140- age)× body weight)/(72× blood Cr) Female: Cr clearance =((140- age)× body weight)/(72× blood Cr) × 0.85 Weight unit: kg; Blood Cr unit: mg/mL; v. Urinary protein < 2+ (if urinary protein = 2+, 24-hour (h) urinary protein quantification can be performed, 24h urinary protein quantification < 1.0g can be included in the group); c) Coagulation function: Activated partial thromboplastin time (APTT) and international normalized ratio (INR) = 1.5×ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin and INR can be screened within the intended therapeutic range of anticoagulants); d) Thyroid stimulating hormone (TSH) = ULN; If abnormal, T3 and T4 levels should be investigated. If T3 and T4 levels are normal, they c
Exclusion criteria
Exclusion criteria: Subjects will not be admitted to the study if they meet any of the following criteria: 1) Within 5 years or at the same time, other active malignant tumors other than BTC. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc., could be included in the group. 2) Patients who are preparing for or have previously received an organ or allogeneic bone marrow transplant; 3) received another investigational drug within 28 days prior to initiation of study treatment; 4) Moderate or severe ascites with clinical symptoms require therapeutic puncture, drainage or Child-Pugh score >2 (except those who only show a small amount of ascites without clinical symptoms); Uncontrolled or moderate or above pleural effusion and pericardial effusion; 5) Have a history of gastrointestinal bleeding within 6 months before the start of the study or have a clear tendency to gastrointestinal bleeding, such as: Patients with bleeding risk or severe esophageal and gastric varices, locally active digestive ulcer lesions, and persistent positive occult blood in stool could not be included in the group (if the stool was positive for occult blood at baseline, it could be re-examined; if the stool was still positive after re-examination, gastroduodenal microscopy (EGD) was required; if EGD suggested bleeding risk, esophageal and gastric varices could not be included in the group); 6) Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before the start of study treatment; 7) Have had intestinal obstruction and/or have had clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to initiation of study therapy, including incomplete obstruction related to pre-existing disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding: 8) Known hereditary or acquired bleeding (e.g. coagulation dysfunction) or thrombotic tendencies, e.g. in hemophiliacs; Is currently or recently (within 10 days prior to the start of study therapy) used full dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin, low-molecular weight heparin permitted); 9) Currently on or recently used (within 10 days before the start of study treatment) aspirin (> 325mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazole; 10) Thrombotic or embolic events occurred within 6 months before the start of study therapy; 11) Have a clinical cardiac condition or disease that is not well controlled, such as: (1) According to the New York Heart Association (NYHA) standards of grade II or higher cardiac insufficiency or heart color ultrasound: LVEF (left ventricular ejection fraction) 450ms (male); QTc > 470ms (female) (QTc interval is calculated by Fridericia formula; If the QTc is abnormal, it can be detected three times at an interval of 2 minutes, and the average value is taken); 12) have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg (based on
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;time to progression;objective remission rate;disease control rate;duration of response;overall survival; | — |
Countries
China
Contacts
Public ContactMin Dong
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed