Advanced Biliary Tract Cancer
Conditions
Keywords
advanced biliary tract cancer, Albumin Paclitaxel, s1, Toripalimab
Brief summary
The investigator's study is a single armed phrase II trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of Toripalimab combining with S1 and Albumin Paclitaxel as first line in patients with advanced Biliary Tract Cancer. treatment continually until disease progression or intolerable toxicity or Patients withdrawal of consent.and target sample is 30+ patients.
Detailed description
Toripalimab: 240 mg , once every 2-3 weeks; S1: 80-120mg, bid; oral, day1-14; Albumin paclitaxel: 120mg/m2 , administered on the first day and the eighth day of each cycle; 21 days for a treatment cycle
Interventions
DRUGToripalimab Combined With S1 and Albumin Paclitaxel
Toripalimab 240 mg ，every 2-3 weeks S1：80-120mg，bid；oral，d1-14； Albumin Paclitaxel：120mg/m2，D 1 \\8
Sponsors
Dai, Guanghai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 2. Patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology 3. Liver function Child-Pugh grade A (5-6 points) or better grade B (≤ 7 points) 4. ECOG score 0 or 1 point 5. At least one measurable lesion 6. no previous treatment
Exclusion criteria
1. organs failure ,including liver ,heart ,kidney 2. Have received a liver transplant in the past 3. Active brain metastasis or spinal cord compression 4. ECOG score 3 or 4 point 5. Symptomatic peripheral neuropathy (CTCAE ≥ 2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 1 year | ORR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | 1 year | PFS |
| disease response rate | 1 year | DCR |
| overall survival | 1 year | OS |
Countries
China
Outcome results
None listed