Biliary tract tumor
Conditions
Interventions
Late first-line treatment population:NA
Postoperative adjuvant treatment population:NA
Sponsors
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants eligible to be enrolled in this study must meet all of the following criteria: 1. Aged >=18 years old and <=75 years old; 2. No gender limitation; 3. Biliary tract tumors confirmed by histopathology or cytology (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, etc.) 4. Received a combination of solantinib, immune checkpoint inhibitors, and chemotherapy for at least 2 cycles 5. ECOG PS 0-1 score 6. Estimated expected survival was < 12 weeks before treatment with a combination of sofantinib, immune checkpoint inhibitors, and chemotherapy. 7. Patients with advanced first-line treatment had at least one measurable lesion (RECIST1.1). 8. At least one radiographic evaluation of efficacy was performed after treatment.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded: 1. Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix; 2. Study patients with drug contraindications, such as significant bleeding tendency, or severe deficiency of liver and kidney function, contraindications of immune checkpoint inhibitors before treatment with the combination of solantinib, immune checkpoint inhibitor and chemotherapy. 3. Other interference-analyzed antitumor agents were also administered during the combination of sofantinib, immune checkpoint inhibitors, and chemotherapy. 4. Estimated expected survival was < 12 weeks before treatment with a combination of sofantinib, immune checkpoint inhibitors, and chemotherapy. 5. Patients whose follow-up information determined by the investigator to be insufficient for analysis (such as those who did not return to the hospital for treatment or efficacy evaluation after the initial treatment) 6. Other acute or chronic diseases, mental illnesses, or abnormalities in laboratory test values that may interfere with the study results. 7. Pregnant or lactating female subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR,Objective response rate;DFS, 3-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR,Disease control rate;PFS,Progression free survival;OS, overall survival; | — |
Countries
China
Contacts
Public ContactSulai Liu
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Outcome results
None listed