Advanced Biliary Tract Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib and Gem-Cis chemotherapy in advanced biliary tract Cancer
Interventions
DRUGCadonilimab+Regorafenib+GC
Cadonilimab:10mg/kg, iv,q3w,D1 Regorafenib: 80mg, po, orally once daily Gemcitabine:1000 mg/m2, iv, Q3W，D1,D8 Cisplatin:25 mg/m2, iv, Q3W, D1,D8
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. subjects with a histopathological or cytologically diagnosis of BTC 2. The participants must be required to sign an informed consent 3. At least one measurable lesion (RECIST 1.1) 4. No previous systematic treatment for BTC 5. Child-Pugh Score, Class A 6. ECOG performance status 0 or 1 7. Adequate organ function 8. Life expectancy of at least 3 months
Exclusion criteria
1. Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma 2. Known history of serious allergy to any monoclonal antibody 3. Known central nervous system metastases and/or leptomeningeal disease prior to treatment 4. Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment 5. Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment 6. Any active malignancy prior to the start of treatment 7. Active or history of autoimmune disease 8. Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation 9. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate ( ORR) per RECIST 1.1 | Up to 1 year | Defined as proportion of patients who have a best response of CR or PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to two years | Defined as the time from enrollment to death from any cause |
| Progress Free Survival (PFS) | Up to two years | Defined as the time from enrollment to disease progression or death (whichever occurs first) |
| Adverse Events (AEs) | Up to two years | Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 |
| Disease control rate (DCR) per RECIST 1.1 | Up to 1 year | Defined as proportion of patients who have CR or PR or SD |
Countries
China
Outcome results
None listed