NCT06685289 is a Phase 2 clinical trial of Donafenib in Biliary Malignant Tumors, sponsored by The First Affiliated Hospital with Nanjing Medical University.

Who is sponsoring NCT06685289?

NCT06685289 is sponsored by The First Affiliated Hospital with Nanjing Medical University.

What drugs are being tested in NCT06685289?

Interventions in NCT06685289: Donafenib, capecitabine.

What condition does NCT06685289 study?

NCT06685289 studies Biliary Malignant Tumors.

Is NCT06685289 still recruiting?

NCT06685289 is currently recruiting now. Last updated 28 January 2025.

Last reviewed 2025-01-28 · How we verify

NCT06685289

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2 Last updated 28 January 2025

What this trial tests

Phase 2 trial testing Donafenib in Biliary Malignant Tumors in 70 participants. Currently enrolling.

Timeline

15 November 2024

Primary endpoint
15 November 2026

15 November 2027

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	15 November 2024
Primary completion	15 November 2026
Estimated completion	15 November 2027
Sites	1 location across China

Drugs / interventions tested

Donafenib — full drug profile →
capecitabine (capecitabine) — full drug profile →

Conditions studied

Biliary Malignant Tumors — all drugs for Biliary Malignant Tumors →

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Adults 18 to 75, any sex, with Biliary Malignant Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Donafenib

Trials testing the same drug.

NCT07353827 — FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarc · Phase 2 · not yet recruiting
NCT07180459 — The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, O · not yet recruiting
NCT06646198 — TIPS Plus Half-dose Donafenib in AHCC with PVTT-associated Portal Hypertension · Phase 2 · recruiting
NCT06609876 — Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC · NA · recruiting
NCT06581315 — Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma · NA · recruiting

Other recruiting trials for Biliary Malignant Tumors

Currently open trials in the same condition.

NCT07368803 — Evaluation of the Safety, Tolerability and Efficacy of iNeo-Vac-R01, an Individualized mRNA Therapeutic Technology Based · Phase 1, PHASE2 · recruiting

Other The First Affiliated Hospital with Nanjing Medical University trials

Trials by the same sponsor.

NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
NCT07523789 — Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC · not yet recruiting
NCT07464756 — SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer · Phase 2 · not yet recruiting
NCT07482826 — Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis · NA · not yet recruiting
NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06685289 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital with Nanjing Medical University
Last refreshed: 28 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06685289.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing