biliary tract cancer
Conditions
Interventions
experimental group:Gemcitabine, Cisplatin and Sintilimab
Sponsors
Department of Medical Oncology, National Center /Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Primary unresectable, infeasible liver transplantation and ablation confirmed by histology, recurrence, metastasis and malignant tumor (including gallbladder cancer, extrahepatic cholangiocarcinoma or intrahepatic cholangiocarcinoma or ampullary cancer) from bile duct epithelium; 2. If the patient has received radiotherapy, radioembolization, chemoembolization, local hepatectomy and local ablation before, it needs to be at least 1 month from the end of the treatment and the treatment-related toxicity has recovered to below level 1. The palliative radiotherapy outside the liver needs to be at least 2 weeks from the end of the treatment and the treatment-related toxicity has recovered to below level 1; 3. Patients with neoadjuvant or adjuvant chemotherapy with gemcitabine and / or cisplatin before or after radical operation of cholangiocarcinoma are allowed, but the end of treatment should be >= 6 months; 4. Patients with at least one non locally treated imaging measurable lesion (according to the recistv1.1 standard); 5. Patients older than 18 years; 6. Patients with ECoG score of 0-1; 7. The patients who have the ability to understand the study voluntarily participate in the study and sign the informed consent; 8. Patients who can tolerate CT enhancement and / or MRI enhancement; 9. Patients with sufficient organ function: on the premise of no component blood transfusion within 14 days: leukocyte >= 3.5 * 10 ^ 9 / L, neutrophil >= 1.5 * 10 ^ 9 / L, hemoglobin >= 90g / L, platelet >= 100 * 10 ^ 9 / L; serum bilirubin = 60ml / min; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= lower limit of normal value (50%).
Exclusion criteria
Exclusion criteria: 1. Patients with HIV positive and other immunodeficiency diseases; 2. Two Patients with autoimmune diseases or other diseases requiring immunosuppressive treatment, except for type I diabetes; hypothyroidism requiring hormone replacement only; skin diseases (such as vitiligo, psoriasis, alopecia areata) requiring no systematic treatment, except for inhaled or topical steroids or equivalent steroids of more than 10 mg prednisone per day The non active autoimmune diseases were excluded; 3. Patients who have received systemic hormone therapy or treatment with daily dose more than 10 mg of prednisone equivalent dose or other forms of immunosuppressive therapy within 7 days, except for the non active autoimmune diseases with inhaled or topical steroids or treatment with daily dose more than 10 mg of prednisone equivalent steroids; 4. Patients with previous organ transplantation history; 5. Patients with brain metastasis; 6. Patients who have undergone major surgery, open biopsy or obvious trauma within one month, or who may need major surgery during the study; patients who have undergone open biopsy or obvious trauma, or who may need major surgery during the study; 7. Patients with other malignant tumors (except for cured skin basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ; other malignant tumors have been treated for more than one year, and there is no clinical and imaging evidence of recurrence and progression); 8. Patients with active and refractory infection; 9. Patients who have been vaccinated with live vaccine within 1 month; Patients with clinically significant cardiovascular disease or bleeding or thrombus events within 10.6 months; 11. Patients with mental illness, serious psychosocial disease or factors that may affect the study compliance according to the researcher; 12. Pregnant or lactating women; 13. Fertile women (less than 2 years after the last menstruation) and men who are reluctant to use effective contraceptive methods; 14. Patients with severe allergic reactions to the test drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;time to response;duration of response;median progression-free survival;median overall survival;12-month survival rate;adverse events rates;serious adverse events rates; | — |
Countries
China
Contacts
Public ContactLin Yang
Department of Medical Oncology, National Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Outcome results
None listed