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New treatment option for Biliary Malignant Tumors
Official title Donafenib Combined With Capecitabine for Postoperative Adjuvant Therapy of Biliary Malignant Tumors With High-risk Recurrence Risk
ClinicalTrials.gov ID: NCT06685289
What this study is testing
What is Donafenib?
Donafenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for biliary malignant tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients must sign an informed consent form;
- Age range: 18-75 years old, both male and female are welcome;
- ECOG Physical Status Score (PS Score) 0 or 1;
- Patients with BTC (intrahepatic cholangiocarcinoma ICC; extrahepatic cholangiocarcinoma ECC gallbladder cancer\&hilar cholangiocarcinoma\&distal...
- According to the UICC/AJCC TNM 8th edition staging system: T2-4, N0, M0 or T1-4, N1, M0 (applicable to ECC people); T1b-4, N0-1, M0 or T1a, N1, M0...
You likely can't join if
- Pathological diagnosis of mixed hepatocellular carcinoma and other non cholangiocarcinoma malignant tumor components;
- Previously received systemic treatment;
- Previous or concurrent malignant tumors, excluding fully treated non melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid...
- Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within the year prior to enrollment; Having a history of active...
- History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus...
- Long term systemic hormone therapy (equivalent to\>10mg prednisone/day) or any other form of immunosuppressive therapy is required. people who use...
See the full eligibility criteria
- Patients must sign an informed consent form;
- Age range: 18-75 years old, both male and female are welcome;
- ECOG Physical Status Score (PS Score) 0 or 1;
- Patients with BTC (intrahepatic cholangiocarcinoma ICC; extrahepatic cholangiocarcinoma ECC gallbladder cancer\&hilar cholangiocarcinoma\&distal cholangiocarcinoma) diagnosed by histopathology after resection of...
- According to the UICC/AJCC TNM 8th edition staging system: T2-4, N0, M0 or T1-4, N1, M0 (applicable to ECC people); T1b-4, N0-1, M0 or T1a, N1, M0 (applicable to ICC people); - Please refer to the screenshot level PDF...
- Vascular invasion;
- Neurophilic invasion (PNI);
- No recurrence or metastasis on imaging within the first 28 days of randomization;
- Prior to radical resection, no anti-tumor systemic therapy (including radiotherapy, chemotherapy, targeted therapy, immunotherapy) was received;
- The laboratory test values within 7 days before the first medication meet the requirements:
- Expected survival period greater than 6 months;
- Women with fertility must agree to abstain from sexual intercourse (avoid heterosexual intercourse) or use reliable and effective methods of contraception for at least 120 days from the date of signing the informed...
- For male participants whose partners are fertile women, they must agree to abstain from sexual activity for at least 120 days from the signing of the informed consent form until the last administration of the study...
- Pathological diagnosis of mixed hepatocellular carcinoma and other non cholangiocarcinoma malignant tumor components;
- Previously received systemic treatment;
- Previous or concurrent malignant tumors, excluding fully treated non melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;
- Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within the year prior to enrollment; Having a history of active pulmonary tuberculosis infection more than one year prior to...
- History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease...
- Long term systemic hormone therapy (equivalent to\>10mg prednisone/day) or any other form of immunosuppressive therapy is required. people who use inhaled or topical corticosteroids may be included;
- Severe heart, lung, and kidney dysfunction;
- Insufficient control of arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) (based on the average of BP readings obtained from ≥ 2 measurements), allowing for the use of...
- Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies; Abnormal coagulation function (PT\>14s), with a tendency towards bleeding or currently...
- HBV DNA\>2000IU/ml, HCV active infection (HCV antibody positive and HCV-RNA level above the detection limit);
- Active infections that require systemic treatment;
- Positive for human immunodeficiency virus (HIV, HIV1/2 antibody);
- Have a history of substance abuse, alcoholism, or drug use;
- Have a history of researching drug allergies;
- Other factors that may affect subject safety or trial compliance, as determined by researchers. Serious illnesses (including mental illnesses) that require combined treatment, severe laboratory abnormalities, or other...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.