REMS Combined With TAI for Unresectable HC

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.

Study Overview

• Status: Completed
• Conditions: Unresectable Hilar Cholangiocarcinoma
• Intervention / Treatment: Procedure: REMS+TAI; Procedure: SEMS+TAI

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Lu, MD; Phone Number: +86 15850654644; Email: lujian43307131@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital,Southeast University
      • Contact: Qi Chen, MD; Phone Number: +86 15651925693; Email: qcyzzhcq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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)

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REMS+TAI; Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma	Procedure: REMS+TAI; Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
Active Comparator: SEMS+TAI; Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma	Procedure: SEMS+TAI; Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency	Time from stent placement to the day when re-stenosis of the stent occurred.	Participants will be followed till die or lost to follow-up, an expected average of a year.
Adverse events	Including side effect/complication, radioactive safety. Complications would be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 4.03).	Participants will be followed till die or lost to follow-up, an expected average of a year.
Relief of jaundice	Relief of jaundice was defined as reduction of more than 20% total bilirubin within 1 week after stent implantation.	Relief of jaundice was evaluated within 1 week after stent implantation.
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.	24 weeks
Time to symptom progression	Symptom progression was defined as when ECOG performance status increased from 0-2 before enrollment to 4 or 5	Participants will be followed till progression appeared or die or lost to follow-up, an expected average of a year.

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Jin-He Guo, MD, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bile duct; Unresectable hilar cholangiocarcinoma; Irradiation stent; Conventional stent; Trans-arterial infusion
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Klatskin Tumor
• Other Study ID Numbers: REMS-TAI-HC-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No