NCT04300959

Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer

Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer: A Randomized, Controlled, Multicenter Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer

Detailed description

Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and c-Kit kinase.It is a randomized, controlled, multicenter phase II clinical trial conducted in China, and plan to recruit 80 patients who were primarily diagnosed with unresectable or metastatic biliary tract cancer who have not received previous systemic treatment.To evaluate the efficacy and safety of Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin	Gemcitabine:1000mg/m2, days 1 and 8; Cisplatin: 25mg/m2, days 1 and 8； Anlotinib : 10mg po qd, days 1-14; Sintilimab: 200mg IV, day 1； 1 cycle = 3 weeks.
DRUG	Gemcitabine Plus(+)Cisplatin	Gemcitabine:1g/m2, days 1 and 8; Cisplatin: 25mg/m2, days 1 and 8； 1 cycle = 3 weeks.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-01-01
• Completion: 2022-01-01
• First posted: 2020-03-09
• Last updated: 2020-03-09

Locations

1 site across 1 country: China