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Unresectable Hilar CholangiocarcinomaNCT04801160

REMS Combined With TAI for Unresectable HC

A study testing REMS+TAI and SEMS+TAI in people with Unresectable Hilar Cholangiocarcinoma, run by Zhongda Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this randomized controlled study is to evaluate the efficacy and safety of the Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) for unresectable hilar cholangiocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable Hilar Cholangiocarcinoma
What is being tested?
REMS+TAI and SEMS+TAI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteChina
Study dates
1 Mar 2021to 15 Jul 2023
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinically or histopathologically diagnosis of cholangiocarcinoma
  • With symptoms such as jaundice related to biliary obstruction
  • Biliary obstruction of Bismuth-Correlate Classification Type III or IV
  • Unresectable disease confirmed by multidisciplinary team
  • Maximum diameter of lesion ≤3 cm
  • Liver function of Child-Pugh A or B
Show all 10Show fewer
  • 18 years older
  • With an expected survival time ≥ 3 months
  • With an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Meet the following laboratory test parameters: hematologic function (absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L; hemoglobin ≥ 90 g/L; INR < 1.7 or prolonged prothrombin time not more than 4 seconds); liver function (ALT/AST not more than 5 times the upper limit of normal; albumin ≥ 28 g/L); renal function (serum creatinine not more than 1.5 times the upper limit of normal)

Who cannot join

  • Presence of distant metastases
  • With another malignancy type other than cholangiocarcinoma
  • Previous history of biliary stent placement
  • Moderate to severe ascites (ascites up to Child-Pugh score of 3)
  • Biliary perforation
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to enrollment
Show all 13Show fewer
  • Unstable angina, myocardial infarction, coronary artery bypass graft, congestive heart failure, cerebrovascular accident (including transient ischemic attack, pulmonary embolism) within 3 months before enrollment
  • Persistent arrhythmia (CTCAE criteria grade 2 and above), atrial fibrillation of any degree, prolonged Qtc interval (more than 450 ms in men and more than 470 ms in women)
  • Refractory hypertension (blood pressure above 150/100 mmHg even after optimal drug therapy
  • Concomitant receipt of other anti-tumor drugs
  • Concomitant human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome
  • Pregnant or lactating women
  • Concomitant acute or chronic mental disorders (including mental disorders affecting subject enrollment, therapeutic intervention, and follow-up)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongda Hospital,Southeast University

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) Versus Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma

The purpose of this randomized controlled study is to evaluate the efficacy and safety of the Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) for unresectable hilar cholangiocarcinoma.

Read the detailed description

This is a multicentric, open-labal, randomized controlled trial which aims to evaluate the efficacy and safety of Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) versus Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma. The primary hypotheses are that Radiation-Emitting Metallic Stents (REMS) combined with Trans-Arterial Infusion (TAI) is superior to Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) with respect to Over survival(OS). The primary endpoint is overall survival. The secondary endpoints include quality of life, progression free survival, relief of jaundice, patency, and adverse events.

Being tested
REMS+TAI, SEMS+TAI
Keywords
Unresectable hilar cholangiocarcinoma, Irradiation stent, Conventional stent, Trans-arterial infusion, Bile duct

What participants receive

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

  • REMS+TAIProcedure or surgery

    Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma

  • SEMS+TAIProcedure or surgery

    Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma

Study groups in NCT04801160
Study groupRoleWhat they receive
REMS+TAIExperimentalRadiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
Receives: Procedure: REMS+TAI
SEMS+TAIActive comparatorUncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
Receives: Procedure: SEMS+TAI

What is being measured

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

  1. Overall survival

    Time from treatment to the day when the patients died or lost to the follow-up.

    Measured: Participants will be followed till die or lost to follow-up, an expected average of a year.

Secondary outcomes (5)

  1. Quality of life assessed by Quality-of-life Questionnaire Core 30

    Quality of life was assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (QLQ-C30), which was completed at different time points: baseline (T0), 4 weeks (T1), 12 weeks (T2), and 24 weeks (T3) after stenting procedures.

    Measured: 24 weeks

  2. Time to symptom progression

    Symptom progression was defined as when ECOG performance status increased from 0-2 before enrollment to 4 or 5

    Measured: Participants will be followed till progression appeared or die or lost to follow-up, an expected average of a year.

  3. Patency

    Time from stent placement to the day when re-stenosis of the stent occurred.

    Measured: Participants will be followed till die or lost to follow-up, an expected average of a year.

  4. Adverse events

    Including side effect/complication, radioactive safety. Complications would be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 4.03).

    Measured: Participants will be followed till die or lost to follow-up, an expected average of a year.

  5. Relief of jaundice

    Relief of jaundice was defined as reduction of more than 20% total bilirubin within 1 week after stent implantation.

    Measured: Relief of jaundice was evaluated within 1 week after stent implantation.

Timeline

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

  1. First posted16 Mar 2021
  2. Study start1 Mar 2021
  3. Primary completion15 Jul 2023
  4. Study completion15 Jul 2023

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04801160
Sponsor's protocol ID
REMS-TAI-HC-2021
Status last verified
Dec 2023
First submitted
15 Mar 2021
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing REMS+TAI and SEMS+TAI in people with Unresectable Hilar Cholangiocarcinoma, run by Zhongda Hospital 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 13 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: finished, as of the sponsor's last update on 18 Dec 2023. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Participants will be followed till die or lost to follow-up, an expected average of a 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 NCT04801160.

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 18 Dec 2023.

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