REMS Combined With TAI for Unresectable HC

NCT04801160 | Completed DMC

• 1 other identifier: REMS-TAI-HC-2021
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable Hilar Cholangiocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

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

Secondary Outcomes (5)

• Quality of life assessed by Quality-of-life Questionnaire Core 30

  24 weeks

• Time to symptom progression

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

• Patency

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

• Adverse events

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

• Relief of jaundice

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

Study Arms (2)

REMS+TAI

EXPERIMENTAL

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

Procedure: REMS+TAI

SEMS+TAI

ACTIVE COMPARATOR

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

Procedure: SEMS+TAI

Interventions

REMS+TAI PROCEDURE

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

REMS+TAI

SEMS+TAI PROCEDURE

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

SEMS+TAI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital,Southeast University

Nanjing, Jiangsu, 210009, China

Location

Study Officials

• Jin-He Guo, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Center of Interventional Radiology & Vascular Surgery

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 16, 2021
• Study Start: March 1, 2021
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)