Clinical trial NCT02966821: Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Biliary Tract Cancer
Keywords: Surufatinib
Biliary Tract Cancer
Second-line
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2016-11-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival (PFS) rate at Week 16
timeFrame: Progression-free survival (PFS) rate at Week 16
Secondary outcomes:
measure: Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
timeFrame: From first dose to within 30 days after the last dose
measure: Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes
timeFrame: From first dose to within 30 days after the last dose
measure: Objective response rate (ORR)
timeFrame: 6 months after the last patient enrolled
measure: Disease control rate (DCR)
timeFrame: 6 months after the last patient enrolled
measure: Duration of response (DoR)
timeFrame: 6 months after the last patient enrolled
measure: Progression-free survival (PFS)
timeFrame: 6 months after the last patient enrolled
measure: Overall survival (OS)
timeFrame: 6 months after the last patient enrolled
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: The 307th Hospital of Military Chinese People's Liberation Army
state: Beijing
city: Ha'erbin
country: China
facility: Heilongjiang Cancer Hospital
state: Heilongjiang
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin medical university cancer institute&hospital
state: Tianjin
Study officials:
affiliation: The 307th Hospital of Military Chinese People's Liberation Army
name: Jianming Xu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: