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REMS Combined With TAI for Unresectable HC

Primary Purpose

Unresectable Hilar Cholangiocarcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

REMS+TAI

SEMS+TAI

About this trial

This is an interventional treatment trial for Unresectable Hilar Cholangiocarcinoma focused on measuring Unresectable hilar cholangiocarcinoma, Irradiation stent, Conventional stent, Trans-arterial infusion, Bile duct

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histological or pathological 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
18-75 years old
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)

Exclusion Criteria:

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
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)

Sites / Locations

Zhongda Hospital,Southeast University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

REMS+TAI

SEMS+TAI

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

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

Secondary Outcome Measures

Quality of life

QoL would be estimated by using European for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Progression free survival

Time from stenting to the day when progression appeared or the patients died from any cause or lost to the follow-up.

Patency

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

Adverse events

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

Relief of jaundice

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

Full Information

NCT ID

NCT04801160

First Posted

March 15, 2021

Last Updated

March 15, 2021

Sponsor

Zhongda Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04801160

Brief Title

REMS Combined With TAI for Unresectable HC

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 2021 (Anticipated)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhongda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unresectable Hilar Cholangiocarcinoma

Keywords

Unresectable hilar cholangiocarcinoma, Irradiation stent, Conventional stent, Trans-arterial infusion, Bile duct

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

REMS+TAI

Arm Type

Experimental

Arm Description

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

Arm Title

SEMS+TAI

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

REMS+TAI

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

SEMS+TAI

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Quality of life

Description

QoL would be estimated by using European for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Time Frame

QoL would be estimated at baseline, at 4 weeks, and at 12 weeks.

Title

Progression free survival

Description

Time from stenting to the day when progression appeared or the patients died from any cause or lost to the follow-up.

Time Frame

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

Title

Patency

Description

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

Time Frame

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

Title

Adverse events

Description

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

Time Frame

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

Title

Relief of jaundice

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological or pathological 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 18-75 years old 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) Exclusion Criteria: 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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Lu, MD

Phone

+86 15850654644

lujian43307131@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin-He Guo, MD

Organizational Affiliation

Zhongda Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongda Hospital,Southeast University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qi Chen, MD

Phone

+86 15651925693

qcyzzhcq@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

REMS Combined With TAI for Unresectable HC

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