Clinical trial · Interventional
Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma
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
NCT02966821CI-TRIAL-00037348completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surufatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surufatinib
- description
- Surufatinib 300mg once-daily
- interventionNames
- Drug: Surufatinib
Primary outcomes (1)
- measure
- Progression-free survival (PFS) rate at Week 16
- timeFrame
- Progression-free survival (PFS) rate at Week 16
- description
- Proportion of patients without PD or death at Week 16
Secondary outcomes (7)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.