Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Biliary Tract Cancer

Intervention / Treatment
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* Drug: Surufatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written Informed Consent Form (ICF) prior to any study specific procedures Aged at least 18 years Histologically or cytologically confirmed advanced BTC that was surgically unresectable or metastatic, including extrahepatic cholangiocarcinoma (EHCC), intrahepatic cholangiocarcinoma (IHCC) or gallbladder biliary carcinoma (GBC) First-line prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities ECOG 0-1 Patients must have measurable lesions Exclusion Criteria: Anti-tumor therapy received within 4 weeks prior to initiation of study treatment Previous therapy with approved or investigational anti-VEGF (or VEGFR) tyrosine kinase inhibitors or monoclonal antibody Liver metastases ≥50% of liver volume Child-Pugh classification score of liver function> 7 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 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 Patients receive CYP3A4 potent inducer or inhibitors within 2 weeks Pregnancy ( positive pregnancy test before the first dose of study treatment) or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surufatinib<br>Surufatinib 300mg once-daily | Drug: Surufatinib<br>* Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)<br>* Other names: HMPL-012 and Sulfatinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) rate at Week 16 | Proportion of patients without PD or death at Week 16 | Progression-free survival (PFS) rate at Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 | AE monitored from the first dose to within 30 days after the last dose | From first dose to within 30 days after the last dose | 
| Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes | Safety parameters monitored from the first dose to within 30 days after the last dose | From first dose to within 30 days after the last dose | 
| Objective response rate (ORR) | Proportion of patients with a best overall CR and PR per RECIST v1.1 | 6 months after the last patient enrolled | 
| Disease control rate (DCR) | Proportion of patients whose best overall response from baseline is either a CR, PR or SD per RECIST v1.1 | 6 months after the last patient enrolled | 
| Duration of response (DoR) | The time from the first time that the objective response reaches CR or PR, whichever comes first, until the occurrence of PD or death | 6 months after the last patient enrolled | 
| Progression-free survival (PFS) | The time from the start date of study drug until the date of objective disease progression or death | 6 months after the last patient enrolled | 
| Overall survival (OS) | The time interval between the start date of study drug and the date of death (any cause) | 6 months after the last patient enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surufatinib, Biliary Tract Cancer, Second-line