Study of Sulfatinib as Second-line Treatment in Patients With Biliary

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

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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)
One 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02966821

Contacts
Contact: Tiffany Li +86 21 2067 3014

Locations
China, Beijing
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100032
Contact: Chunmei Bai, Prof.
The 307th Hospital of Military Chinese People’s Liberation Army Not yet recruiting
Beijing, Beijing, China, 100071
Contact: Jianming Xu, Prof.
China, Heilongjiang
Heilongjiang Cancer Hospital Not yet recruiting
Ha’erbin, Heilongjiang, China, 150040
Contact: Yuxian Bai, Prof.
China, Shanghai
Shanghai Zhongshan Hospital Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Huichuan Sun, Prof.
China, Tianjin
Tianjin medical university cancer institute&hospital Not yet recruiting
Tianjin, Tianjin, China, 300060
Contact: Tianqiang Song, Prof.
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
Principal Investigator: Jianming Xu, Prof. The 307th Hospital of Military Chinese People’s Liberation Army
More Information

Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02966821 History of Changes
Other Study ID Numbers: 2016-012-00CH1
Study First Received: November 11, 2016
Last Updated: November 16, 2016
Health Authority: China: Food and Drug Administration
Individual Participant Data
Plan to Share IPD: No