NCT06685289

Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recurrence Risk

Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recurrence Risk: a Multi-center, Randomized Controlled, Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, open label, parallel controlled trial aimed at evaluating and observing the efficacy and safety of the combination of donafenib and capecitabine as adjuvant therapy for postoperative treatment of biliary malignancies with high risk of recurrence. The study selected patients with biliary malignant tumors who are at high risk of postoperative recurrence as the research subjects. After the subjects sign the informed consent and pass the screening, they will be randomly divided into 1:1 groups. The experimental group consisted of Donafenib (200mg, bid) combined with capecitabine (1250mg/m2, bid, treated for 2 weeks and stopped for 1 week). The control group was capecitabine (1250mg/m2, bid, treated for 2 weeks and stopped for 1 week). Stop treatment until the subject experiences disease recurrence or intolerable toxic side effects. The primary endpoint of the study was the 1y RFS rate. Plan to include 70 participants.

Conditions

• Biliary Malignant Tumors

Interventions

Type	Name	Description
DRUG	Donafenib	200mg, oral, twice daily, continuous medication for 6 months
DRUG	capecitabine	1250mg/m2, oral, twice daily, treatment for 2 weeks with 1 week off, with 3 weeks as a treatment cycle (a total of 8 treatment cycles)

Timeline

• Start date: 2024-11-15
• Primary completion: 2026-11-15
• Completion: 2027-11-15
• First posted: 2024-11-12
• Last updated: 2025-01-28

Locations

1 site across 1 country: China