Status:
NOT_YET_RECRUITING
Neoadjuvant PDT in the Treatment of Cholangiocarcinoma
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Cholangiocarcinoma Resectable
Eligibility:
All Genders
18-75 years
Phase:
NA
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 c...
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 exten...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04824742
Start Date
April 1 2021
End Date
April 1 2028
Last Update
April 1 2021
Active Locations (1)
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1
Yi Lv
Xi'an, Shaanxi, China, 710061