Actively Recruiting
Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recurrence Risk
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-01-28
70
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recurrence Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must sign an informed consent form
- Age between 18 and 75 years old, any gender
- ECOG Physical Status Score of 0 or 1
- Diagnosed with biliary tract cancer (including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer) confirmed by pathology after surgery with R0 resection
- Have at least one high-risk recurrence factor based on UICC/AJCC TNM staging or vascular or neurophilic invasion
- No recurrence or metastasis detected on imaging within 28 days after randomization
- No prior anti-tumor systemic therapy before surgery
- Laboratory tests within 7 days before first medication meet study requirements
- Expected survival longer than 6 months
- Women with fertility must agree to use effective contraception and have negative pregnancy test before randomization; must not be lactating
- Male participants with fertile partners must agree to use effective contraception and not donate sperm during the study period
You will not qualify if you...
- Mixed hepatocellular carcinoma or other non-cholangiocarcinoma malignant tumor components
- Previous systemic treatment for cancer
- Previous or concurrent malignant tumors except treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma
- Active tuberculosis infection within the past year or untreated history of tuberculosis
- History of autoimmune diseases or immunodeficiency disorders
- Need for long-term systemic hormone or immunosuppressive therapy (inhaled or topical corticosteroids allowed)
- Severe heart, lung, or kidney dysfunction
- Poorly controlled high blood pressure or history of hypertensive crisis
- Recent significant bleeding or abnormal blood clotting
- Active hepatitis B or C infection
- Active infections requiring systemic treatment
- Positive HIV test
- History of substance abuse, alcoholism, or drug use
- Known allergies to study drugs
- Other serious illnesses or conditions affecting safety or study compliance as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
J
Jianhua Rao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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