Biliary tract cancers
Conditions
Interventions
Chemo holiday group:(1) GC chemo holiday (2) Lenvatinib (3) Triprilizumab
Sponsors
Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participate in this study voluntarily and sign the informed consent; 2. 18-80 years old and ECOG:0-1; 3. Biopsy of biliary tract cancers 4. The immunotype was immuno-nonprogressive type; 5. Unresectable biliary tract cancer is defined as an inability to achieve curative resection by radical surgery (including vascular resection) and should meet one of the following requirements, including (I) solid tumor >180° contact with the hepatic artery; (II) tumor invades the portal vein and cannot be reconstructed; (III) extensive bile duct infiltration that cannot be radically resected; (IV) extensive liver invasion that cannot be resected due to insufficient remnant liver volume even after portal vein embolization; 6. At least 1 measurable lesion is present in CT/MRI according to RECIST1.1 standard. 7. The function indexes of important organs meet the following requirements: neutrophils >= 1.5*10^9/L; platelets >= 90*10^9/L; hemoglobin >= 9g/dl; serum albumin >= 3.5g/dl; coagulation function: international standardization ( Prothrombin time) ratio (INR) = 60ml/min; 8. Contraception during or 3 months after treatment.
Exclusion criteria
Exclusion criteria: 1. Patients who have received systemic therapy with PD-1 antibody, PD-L1 antibody or CTLA4 antibody, TKI inhibitor, chemotherapy in the past; participated in other clinical trials 30 days previously; 2. Suffering from other malignant tumors in the past or at the same time; 3 Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within one year before treatment; patients with active tuberculosis infection history more than one year before treatment; patients who have not received regular anti-tuberculosis treatment or are still in active tuberculosis; 4. Suffering from active, known or suspected autoimmune disease. Patients with hypothyroidism who only receive hormone replacement therapy or patients who have skin diseases that do not require systemic therapy can be enrolled; 5. Patients have interstitial lung disease or (non-infectious) pneumonia, and need oral or intravenous steroid therapy; 6. Long-term systemic corticosteroids (dose equivalent to >10mg prednisone/day) or any other form of immunosuppressive therapy. Patients using inhaled or topical corticosteroids may be enrolled; 7. Active infection requiring systemic therapy; 8. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive; 9. Significant bleeding symptoms or a clear tendency that appear within 3 months before treatment; 10. Vulnerable groups including mentally ill, cognitively impaired, critically ill patients, minors, pregnant women, lactating women, illiterate, etc. Known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positive (> 1*104 copies/ml or >2000 IU/ml); Hepatitis C virus (HCV) is known and HBV DNA is positive (>1*103 copies/ml), or other hepatitis, cirrhosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;chemotherapy completion;adverse events;severe adverse events;quality of life;overall survival; | — |
Countries
China
Contacts
Public ContactMingyu Chen
Outcome results
None listed