biliary tract carcinoma
Conditions
Interventions
trail group:Sintilimab combined with Tiggio regimen
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent before enrollment; agree to follow-up in accordance with the requirements of the study design. 2. Aged 18-75 years, both male and female; 3. Primary cholangiocarcinoma confirmed by histopathology (intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma), gallbladder cancer, inoperable locally advanced or advanced cholangiocarcinoma or gallbladder cancer confirmed by imaging; 4. No tumor progression after receiving first-line chemotherapy; 5. Have measurable lesions that meet the RECIST v1.1 standard for evaluation or CR after first-line chemotherapy; 6. ECOG score: 0 or 1; 7. The expected survival period is longer than 6 months; 8. The functions of vital organs meet the following requirements (not including the use of any blood components and cell growth factors within 14 days): (1) The standard of routine blood examination must meet (no blood transfusion and blood products within 14 days): a. ANC >= 1.5*10^9/L; b. PLT >= 80*10^9/L; c. Hb >= 5.6 mmol/L (9g/dL); (2) The biochemical inspection shall meet the following standards: a. TBIL 60ml/min (Cockcroft-Gault formula); 9. Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive measure (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period; Female patients of childbearing age who undergo surgical sterilization must be negative in serum or urine HCG within 7 days before enrollment in the study; and must be non-lactating; male patients of childbearing age who are not surgically sterilized or of childbearing age must agree with their spouse during the study treatment period and the study Use a medically approved contraceptive method within 3 months after the end of the treatment period. 10. Subjects voluntarily join the study, with good compliance, and safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis , Hyperthyroidism, decreased thyroid function; subjects suffering from vitiligo or asthma in childhood has been completely relieved, no intervention after adults can be included; subjects requiring bronchodilators for medical intervention can not be included); 2. The subject is using immunosuppressive agents or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use; 3. Severe allergic reaction to other monoclonal antibodies; 4. Cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinical significance Supraventricular or ventricular arrhythmia requires treatment or intervention; (5) QTc>450ms (male); QTc>470ms (female); 5. Abnormal coagulation function (INR > 1.5 or PT > 16s), bleeding tendency or receiving thrombolysis or anticoagulation therapy; 6. Subjects who have previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy, after the completion of the treatment (last medication), less than 4 weeks before the study medication (or 5 drug half-lives, whichever is longer); patients whose adverse events (except alopecia) caused by previous treatment have not recovered to 38.5 degrees during the screening period and before the first administration; 11. Past and present patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 12. Subjects with congenital or acquired immune deficiencies (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA test value exceeds the upper limit of normal; hepatitis C reference: HCV virus titer or RNA test value exceeds the upper limit of normal ), active or chronic hepatitis B or C that cannot be controlled by antiviral therapy. 13. Those who have used other drugs in clinical trials within 4 weeks before the first drug use; 14. The subject has previously or simultaneously suffered from other malignant tumors (except cured skin basal cell carcinoma and cervical carcinoma in situ); 15. The subject may receive other systemic anti-tumor treatments during the study period; 16. The subject has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1; 17. Live vaccines may be vaccinated within 4 weeks before study medication or may be adm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of response;Adverse event rate; | — |
Countries
China
Contacts
Public ContactZhu Qing
West China Hospital, Sichuan University
Outcome results
None listed