Biliary Tract Cancer
Conditions
Keywords
Surufatinib, Biliary Tract Cancer, Second-line
Brief summary
A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma
Detailed description
This study adopt Simon's two-stage designs method based on the primary endpoint of 16-week PFS rates. In the first stage, 16 patients will be recruited. If there are 3 or fewer patients without progression or death out of these 16 patients at week 16, the study will be stopped. Otherwise, 16 additional patients will be accrued for a total of 32 evaluable patients. Surufatinib will be orally administered within 1 hour after breakfast once a day (QD) for every 28-day treatment cycle until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met (which comes first).
Interventions
DRUGSurufatinib
Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)
Sponsors
Hutchison Medipharma Limited
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. Provision of written Informed Consent Form (ICF) prior to any study specific procedures 2. Aged at least 18 years 3. Histologically or cytologically confirmed advanced BTC that was surgically unresectable or metastatic, including extrahepatic cholangiocarcinoma (EHCC), intrahepatic cholangiocarcinoma (IHCC) or gallbladder biliary carcinoma (GBC) 4. First-line prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities 5. ECOG 0-1 6. Patients must have measurable lesions
Exclusion criteria
1. Anti-tumor therapy received within 4 weeks prior to initiation of study treatment 2. Previous therapy with approved or investigational anti-VEGF (or VEGFR) tyrosine kinase inhibitors or monoclonal antibody 3. Liver metastases ≥50% of liver volume 4. Child-Pugh classification score of liver function\> 7 5. History or presence of a serious hemorrhage (\>30 ml within 3 months), hemoptysis (\>5 ml blood within 4 weeks) or a thromboembolic event (including transient ischemic attack and/or stroke events) within 12 months 6. Active malignancy (except for definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 5 years 7. Patients receive CYP3A4 potent inducer or inhibitors within 2 weeks 8. Pregnancy ( positive pregnancy test before the first dose of study treatment) or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) rate at Week 16 | Progression-free survival (PFS) rate at Week 16 | Proportion of patients without PD or death at Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes | From first dose to within 30 days after the last dose | Safety parameters monitored from the first dose to within 30 days after the last dose |
| Objective response rate (ORR) | 6 months after the last patient enrolled | Proportion of patients with a best overall CR and PR per RECIST v1.1 |
| Disease control rate (DCR) | 6 months after the last patient enrolled | Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1 |
| Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 | From first dose to within 30 days after the last dose | AE monitored from the first dose to within 30 days after the last dose |
| Progression-free survival (PFS) | 6 months after the last patient enrolled | The time from the start date of study drug until the date of objective disease progression or death |
| Overall survival (OS) | 6 months after the last patient enrolled | The time interval between the start date of study drug and the date of death (any cause) |
| Duration of response (DoR) | 6 months after the last patient enrolled | The time from the first time that the objective response reaches CR or PR, whichever comes first, until the occurrence of PD or death |
Countries
China
Outcome results
None listed