NCT06463548

Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma

Clinical Study of Irinotecan Hydrochloride Liposome Injection Combined With Capecitabine and Lenvatinib for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yunpeng Liu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.

Detailed description

To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma. Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle. Drug: Irinotecan hydrochloride liposome injection (70mg/m2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle. Drug: Capecitabine (850 mg/m2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle. Drug: Lenvatinib (8 mg) will be administered orally in a 2-week treatment cycle, once a day from day 1 to day 14 of each cycle.

Conditions

• Biliary Tract Carcinoma

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride liposome injection	Irinotecan hydrochloride liposome injection (70mg/m2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
DRUG	Capecitabine	Capecitabine (850 mg/m2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle.
DRUG	Lenvatinib	Lenvatinib (8 mg) will be administered orally in a 2-week treatment cycle, once a day from day 1 to day 14 of each cycle

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-06-18
• Last updated: 2024-06-18

Locations

1 site across 1 country: China