Cholangiocarcinoma
Conditions
Interventions
experimental group:Simultaneous radiotherapy and chemotherapy combined with PD-1
Sponsors
Shandong Institute of Cancer Prevention and Control
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before joining the trial 2. Aged 18-75, both male and female; 3. Primary cholangiocarcinoma (intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma) confirmed by histology, local advanced cholangiocarcinoma confirmed by pathology and imaging, stage T4N0M0, T1-4N+M0, stage IIIB-IIIc, clinical stage of cholangiocarcinoma; 4. Patients are Evaluated before treatment who can not be carried out surgery or refused surgery; 5. There are measurable lesions that can be evaluated according to the RECIST v1.1 standard. 6. ECOG score: 0-1; 7. Survival expectation >=6 months. 8. The function of important organs shall meet the following requirements: (1) The blood routine examination should be in accordance with standard (no blood transfusion or blood products within 14 days): A. ANC >= 1.5 x 10^9 / L; B. PLT >= 80 x 10^9 / L; C. HB >= 5.6 mmol / L (9g / dL); (2) Biochemical examination shall meet the following standards: A. The normal range of TBIL (3.7-17.1umol / L) or TBIL after PTCD drainage was less than 2 times of the normal value. B. ALT and AST 60ml / min (Cockcroft Gault formula); 9. During the study and within 3 months after the end of the study, the non-surgical sterilization or childbearing age female patients need to use a medically recognized contraceptive measure (such as IUD, contraceptive pill or condom); the serum or urine HCG test of the non-surgical sterilization female patients in the study must be negative within 7 days before the enrollment; and they must be non lactation; non-surgical Male patients of sterilization or childbearing age need to agree to use a medically recognized contraceptive measure with their spouses during the study treatment period and within 3 months after the end of the study treatment period. 10. The subjects voluntarily participated in the study, with good compliance, safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; the subject has vitiligo or asthma in childhood has been completely relieved, no need for any intervene in adult. Asthma patients who need bronchodilator for medical intervention can not be included. 2. The subjects are using immunosuppressant, or systemic, or absorbable local hormone treatment to achieve the purpose of immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones), and they are still in use within 2 weeks before the group; 3. Severe allergic reaction to other monoclonal antibodies; 4. There are clinical symptoms or diseases of the heart that can not be well controlled, such as: (1) NYHA of grade 2 or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction within one year; (4) clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; (5) QTc > 450ms (male); QTc > 470ms (female); 5. Abnormal coagulation (INR > 1.5 or PT > 16S), bleeding tendency or undergoing thrombolysis or anticoagulation; 6. Patients who received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy before the study were less than 4 weeks (or 5 drug half-lives, pick one whichever is longer) after the completion of the treatment (the last medication); patients who did not recover to 38.5 degrees. 11. Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc. 12. Innate or acquired immune deficiency (such as HIV infection) or active hepatitis (HBV reference: HBV DNA detection value exceeds the upper limit of normal value; HCV reference: HCV titer or RNA detection value exceeds the upper limit of normal value); 13. Those who have used other drugs in clinical trials or similar treatment drugs within 4 weeks before the first use of drugs; 14. The subjects had or had other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 15. Subjects may receive other systemic anti-tumor treatment during the study period; 16. Inoculate live vaccine less than 4 weeks before the study medication or possibly during the study period; 17. According to the researcher's judgment, there are other factors that may cause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactJinbo Yue
Shandong Institute of Cancer Prevention and Control
Outcome results
None listed