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Biliary CarcinomaPhase 2NCT03609489

A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma

A Phase 2 study testing Capecitabine and Apatinib in people with Biliary Carcinoma, run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Carcinoma
What is being tested?
Capecitabine and Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
10 Sep 2018to 25 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Fully aware of the research and voluntarily signed informed consent (informed consent must be signed prior to the execution of any required test procedure);
  • Patients received removal of biliary tract cancers that have been confirmed by histology or cytology, including intrahepatic bile duct carcinoma (IHCC), extrahepatic bile duct cancer (EHCC), and gallbladder cancer(GBC);
  • Normal function of major organs that meets the following criteria:
  • Blood routine examination:
  • HB≥90 g/L； ANC≥1.5×109/L； PLT≥60×109/L；
  • Biochemical examination:
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  • ALB ≥29 g/L； ALT and AST<2.5ULN； TBIL ≤2ULN； Creatinine≤1.5ULN;
  • ECOG physical condition scores 0 or 1;
  • Fertile male or female patients volunteer to use effective contraception methods during the research period, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc.
  • Fertile and non-lactational female who show negative in serum or urine pregnancy test within 7 days before inclusion for the study.

Who cannot join

  • Those who received approved or on-going anti-tumor therapy within 4 weeks before the research;
  • Those who received other anti-angiogenic tyrosine kinase inhibitors or monoclonal antibodies that had been approved or under study before the research;
  • Abnormal laboratory tests that have significant clinical implication;
  • International normalized ratio (INR) ≥ 1.5 or partially activated prothrombin time (APTT) ≥ 1.5 × ULN;
  • The patient's current serum potassium, serum magnesium, or serum calcium is below the normal reference range of laboratory test (whether supplemented or not), or >CTCAE grade 1;
  • Patients currently suffering from hypertension that cannot be controlled with drugs;
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  • The researchers conclude electrolyte abnormalities that are clinically significant;
  • There is severe bleeding or hemoptysis in the past or at current stage, or there are thromboembolic events within 12 months;
  • Cardiovascular diseases that are clinically significant;
  • ECG showed QTcB interval ≥ 480 milliseconds in resting state;
  • Suffering from other malignant tumors in the past 5 years, excluding basal cell carcinoma or squamous cell carcinoma after receiving radical surgery, or carcinoma in situ of cervix;
  • Active or uncontrollable serious infection (≥ CTCAE grade 2 infection), including but not limited to human immunodeficiency virus (HIV) infection;
  • Known history of liver disease with evident significance;
  • The patient currently has brain metastasis or spinal compression, except individual cases.

Trial locations and contacts

1 site in 1 country.

Jie Ma, doctor contact

18994127461

18994127461@163.com

China1 site

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Jie Ma, doctor

Other trials in China

About this study

Official title: Apatinib Combined Capecitabine Versus Capecitabine Alone for Adjuvant Therapy in Patients After Biliary Carcinoma Surgery: a Prospective Randomized Controlled Study

It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation.

Read the detailed description

Subjects were randomly divided into experimental and control groups. The experimental group was postoperatively treated with apatinib combined with capecitabine for adjuvant therapy of biliary cancer, and the control group was treated with capecitabine alone.

Progression free survival (PFS), overall survival (OS), time to progression (TTP), objective response rate (ORR), disease control rate (DCR), EORTC QLQ-C30, HCC-18 and drug safety: vital signs, laboratory indicators, adverse event (AE), and serious adverse event (SAE), drug-related AE and SAE and their specific AE (such as hypertension, proteinuria, and hand-foot syndrome) were followed for research in the two groups to evaluate the efficacy and safety of the two regimens for the treatment of biliary tract cancer according to the standard of NCI-CTCAE V4.0.

A rigorous, randomized and prospective study was conducted to compare the efficacy and safety in treating biliary cancer between the combined use of apatinib mesylate plus capecitabine and capecitabine alone, with a view to improving the survival outcome and life quality of patients with biliary tract cancer.

Being tested
Capecitabine, Apatinib
Keywords
Biliary cancer, adjuvant therapy, apatinib, capecitabine
Medical subject headings
Biliary Tract Neoplasms

What participants receive

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

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine, 1000mg/m2, oral administration, twice daily (once in the morning and once in the evening with an interval of 12 hours, equivalent to a total daily dose of 2000 mg/m2), continuous medication for 14 days and off for 7 days. Every 21 days is a cycle, and there shall be a total of 8 cycles. If the subject is still unable to tolerate toxicity after experiencing two dose adjustments, he/she should be moved out of the group.

  • ApatinibDrug

    Also called Aitan

    Apatinib, 500 mg, administered orally (after breakfast) once daily from day 1 to day 21 (including day 21) with continuous administration. Every 21 days serve as a cycle. If after 2 dose adjustments, the subject is still unable to tolerate toxicity, he/she should be moved out of the group.

Study groups in NCT03609489
Study groupRoleWhat they receive
Test GroupExperimentalApatinib combined with Capetabine
Receives: Drug: Capecitabine; Drug: Apatinib
Control GroupActive comparatorCapecitabine
Receives: Drug: Capecitabine

What is being measured

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

  1. Progression-free survival

    the length of time during the recruiment and after the progression of the biliary cancer verified by imagine examination

    Measured: 12 months

Secondary outcomes (3)

  1. overall survival

    the length of time during the recruitment and after the death of the patient

    Measured: 24 months

  2. objective response rate

    The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete response and partial response cases

    Measured: 24 months

  3. Disease Control rate

    The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including complete response, partial response and stable disease cases

    Measured: 24 months

Timeline

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

  1. First posted1 Aug 2018
  2. Study start10 Sep 2018 (estimated)
  3. Primary completion10 Jun 2021 (estimated)
  4. Study completion25 Dec 2021 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03609489
Sponsor's protocol ID
HRGX05
Status last verified
Aug 2018
First submitted
24 Jul 2018
Last updated
9 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Luvira V, Satitkarnmanee E, Pugkhem A, Kietpeerakool C, Lumbiganon P, Pattanittum P. Postoperative adjuvant chemotherapy for resectable cholangiocarcinoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD012814. doi: 10.1002/14651858.CD012814.pub2.

    PubMed 34515993

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Capecitabine and Apatinib in people with Biliary Carcinoma, run by First Affiliated Hospital of Guangxi 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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 Aug 2018. 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?

Results are not available in the source record.

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

Contact Jie Ma, doctor (18994127461, 18994127461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 12 months). 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 NCT03609489, which also lists 1 linked publication.

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 9 Aug 2018.

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