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Neoadjuvant PDT in the Treatment of Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT04824742
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
For patients with locally advanced cholangiocarcinoma with resectable margins, patients who meet the selection criteria are randomly divided into two groups A and B. Group A: neoadjuvant PDT therapy combined with radical surgery; Group B: radical surgery. This study aims to explore the clinical effectiveness and safety of neoadjuvant photodynamic therapy for cholangiocarcinoma, as well as its role in destroying local tumors and enhancing systemic inflammation.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Resectable Procedure: Neoadjuvant PDT + radical surgery Procedure: Radical surgery Not Applicable

Detailed Description:
The average 5-year survival rate of patients with cholangiocarcinoma is about 5-10%. Only 30%-40% of patients have the opportunity to obtain radical surgery. Surgical resection is limited by the extent of tumor spread along the bile duct branches and segments, and the degree of involvement of the portal vein and (or) hepatic artery branches. Complete resection with negative margins (R0) is the only possible radical treatment. Only 60%-78% of radical surgery for cholangiocarcinoma are considered to achieve true R0 resection, and the tumor-free margin is often very short. Even after R0 resection, the recurrence rate is as high as 50%-76%. Photodynamic therapy is a tumor specific ablation method with small side effects and repeated treatments will not produce drug resistance. It provides a new prospect for the treatment of cholangiocarcinoma. For the current patients with locally advanced cholangiocarcinoma, neoadjuvant photodynamic therapy is used to make them resectable. Demotion and subsequent resection may potentially improve their results. Similarly, patients with resectable margins can benefit from tumor downgrading by increasing their chances of undergoing R0 resection. In order to increase the negative rate of resection margins, and to ensure sufficient tumor-free margins of the bile duct stumps, the research is still blank. For patients with locally advanced cholangiocarcinoma with resectable margins, patients who meet the selection criteria are randomly divided into two groups A and B. Group A: neoadjuvant PDT therapy combined with radical surgery; Group B: radical surgery. This study aims to explore the clinical effectiveness and safety of neoadjuvant photodynamic therapy, as well as its role in destroying local tumors and enhancing systemic inflammation.This study plans to enroll 50 patients. It is planned to complete the enrollment operation within 2 years, and the follow-up observation will be continued for 5 years after the operation. All patients are expected to complete neoadjuvant PDT treatment and radical surgery within 2 years, survival period (5 years survival rate), R0 resection rate and local recurrence rate are the main observation indicators, and the bilirubin level, the number of intraoperative freezing, the length of the tumor-free margin of the tumor tissue, and the incidence of complications (biliary leakage, cholangitis, phototoxicity) are the secondary observation indicators.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Study of Neoadjuvant PDT in the Treatment of Cholangiocarcinoma
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: neoadjuvant PDT + radical surgery
Photodynamic therapy for neoadjuvant treatment of cholangiocarcinoma
Procedure: Neoadjuvant PDT + radical surgery
Patients with cholangiocarcinoma will undergo radical surgery after photodynamic therapy

Active Comparator: radical surgery
Patients with cholangiocarcinoma undergo radical surgical resection
Procedure: Radical surgery
Patients with cholangiocarcinoma will only receive radical surgery




Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: During operation ]
    Compare the incidence of positive margins of bile duct after surgical resection of cholangiocarcinoma between the two groups

  2. Local recurrence rate [ Time Frame: 1-year post operation ]
    Compare the local recurrence rate of cholangiocarcinoma between the two groups

  3. Survival time [ Time Frame: 5-year post operation ]
    Compare the 5-year survival time of the two groups


Secondary Outcome Measures :
  1. Bilirubin level [ Time Frame: 1,3,6,12-month post operation ]
    Compare the Bilirubin level of the two groups

  2. Complication rate [ Time Frame: 1, 2,3,4,5,6,7,8-week Post operation ]
    Compare the incidence of bile leakage, cholangitis, phototoxicity and other complications between the two groups

  3. Tumor-free margin length [ Time Frame: During operation ]
    Compare the length of the tumor-free margin of the two groups of cholangiocarcinoma tissues



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with age between 18 to 75 years;
  • Patients'gender was not limited;
  • Patients with locally advanced cholangiocarcinoma who have a clear diagnosis of the primary disease and require surgical resection or potential surgical resection;
  • No history of radiotherapy and chemotherapy;
  • Willing to accept this clinical trial, sign informed consent and be able to cooperate with follow-up.

Exclusion Criteria:

  • Women during pregnancy or breastfeeding, and those with mental illness;
  • Patients allergic to porphyrin drugs, porphyria;
  • Long-term use of glucocorticoids or autoimmune suppression;
  • Surgical contraindication, including:

Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long- term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04824742


Contacts
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Contact: Yi Lv, MD,PHD 86-29-85323900 luyi169@126.com
Contact: Rongfeng Wang, MD 86-29-85324467 15877553630@163.com

Locations
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China, Shaanxi
Yi Lv
Xi'an, Shaanxi, China, 710061
Contact: Yi Lv, MD,PHD    0086-13991200581    luyi169@126.com   
Contact: Xiaogang Zang, MD    0086-15877553630    15877553630@163.com   
Principal Investigator: Yi Lv, MD,PHD         
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Yi Lv, MD,PHD China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity
Publications:
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04824742    
Other Study ID Numbers: 2020ZDLSF04-08
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Cholangiocarcinoma,Neoadjuvant therapy,Photodynamic therapy
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms