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Biliary Malignant TumorsPhase 2NCT06685289

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

A Phase 2 study testing Donafenib and capecitabine in people with Biliary Malignant Tumors, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Malignant Tumors
What is being tested?
Donafenib and capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
15 Nov 2024to 15 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 specimens, R0 resection and having at least one of the following high-risk recurrence factors;
  • According to the UICC/AJCC TNM 8th edition staging system: T2-4, N0, M0 or T1-4, N1, M0 (applicable to ECC subjects); T1b-4, N0-1, M0 or T1a, N1, M0 (applicable to ICC subjects); - Please refer to the screenshot level PDF file at the end of the article for the installment standards
  • Vascular invasion;
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  • 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 consent form until the last administration of the study drug. And the serum HCG test must be negative within 72 hours before randomization; And it must be non lactating.
  • If a woman has already menstruated, has not yet reached postmenopausal status (continuous absence of menstruation for ≥ 12 months, no other reasons found besides menopause), and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), she is considered to have fertility.
  • 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 drug, or to use reliable and effective methods of contraception. Male participants must also agree not to donate sperm during the same time period. Male participants whose partners are already pregnant are required to use condoms and do not need to use other contraceptive methods.

Who cannot join

  • 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 enrollment, not receiving formal anti tuberculosis treatment, or having active tuberculosis;
  • History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barr é syndrome, or multiple sclerosis;
  • Long term systemic hormone therapy (equivalent to>10mg prednisone/day) or any other form of immunosuppressive therapy is required. Subjects who use inhaled or topical corticosteroids may be included;
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  • 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 antihypertensive therapy to achieve the above parameters; Previously experienced hypertensive crisis or hypertensive encephalopathy;
  • 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 undergoing thrombolytic or anticoagulant therapy;
  • 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 family or social factors.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianhua Rao contact

18262637266

raojh@njmu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Jianhua Rao, +8618262637266, raojh@njmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read more

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.

Being tested
Donafenib, capecitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DonafenibDrug

    200mg, oral, twice daily, continuous medication for 6 months

  • capecitabineDrug

    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)

Study groups in NCT06685289
Study groupRoleWhat they receive
donafenib combined with capecitabineExperimentalNot described
Receives: Drug: Donafenib; Drug: capecitabine
capecitabineActive comparatorNot described
Receives: Drug: capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year disease free survival rate

    After receiving treatment, the patient did not experience any disease recurrence within one year

    Measured: 1 year

Secondary outcomes (4)

  1. 2-year disease free survival rate

    After receiving treatment, the patient did not experience any disease recurrence within 2 years

    Measured: 2 year

  2. RFS(Recurrence-free Survival)

    The time elapsed from the date of enrollment to tumor recurrence or death from any cause (if the subject dies before disease recurrence).

    Measured: 3 year

  3. OS(Overall Survival)

    The time elapsed from the date of enrollment to the date of death caused by any reason.

    Measured: 5 year

  4. Safety assessment

    Incidence, severity, and relationship to study drugs of all adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start15 Nov 2024
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion15 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06685289
Sponsor's protocol ID
2024-SR-727
Status last verified
Jan 2025
First submitted
6 Nov 2024
Last updated
28 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donafenib and capecitabine in people with Biliary Malignant Tumors, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianhua Rao (18262637266, raojh@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year disease free survival rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06685289.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.

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