Status:
COMPLETED
REMS Combined With TAI for Unresectable HC
Lead Sponsor:
Zhongda Hospital
Conditions:
Unresectable Hilar Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 hil...
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) ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2023
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04801160
Start Date
March 1 2021
End Date
July 15 2023
Last Update
December 18 2023
Active Locations (1)
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1
Zhongda Hospital,Southeast University
Nanjing, Jiangsu, China, 210009