NCT04824742Not yet recruiting
Neoadjuvant PDT in the Treatment of Cholangiocarcinoma
A Prospective Randomized Controlled Study of Neoadjuvant PDT in the Treatment of Cholangiocarcinoma
Source: ClinicalTrials.gov · Last updated 1 Apr 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 24 Mar 2021
- Start date
- Apr 2021
- Primary completion date
- Apr 2023
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04824742
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Apr 2021 to the primary completion date, Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yi Lv Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.