Neoadjuvant PDT in the Treatment of Cholangiocarcinoma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Women during pregnancy or breastfeeding, and those with mental illness;

Patients allergic to porphyrin drugs, porphyria;

Long-term use of glucocorticoids or autoimmune suppression;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neoadjuvant PDT + radical surgery

    Procedure/Surgery

    Patients with cholangiocarcinoma will undergo radical surgery after photodynamic therapy

  • Radical surgery

    Procedure/Surgery

    Patients with cholangiocarcinoma will only receive radical surgery

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: neoadjuvant PDT + radical surgeryExperimental treatment 1 intervention
Group B: radical surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

R0 resection rate

Compare the incidence of positive margins of bile duct after surgical resection of cholangiocarcinoma between the two groups

Time frame
During operation
2

Local recurrence rate

Compare the local recurrence rate of cholangiocarcinoma between the two groups

Time frame
1-year post operation
3

Survival time

Compare the 5-year survival time of the two groups

Time frame
5-year post operation

Secondary outcomes

1

Bilirubin level

Compare the Bilirubin level of the two groups

Time frame
1,3,6,12-month post operation
2

Complication rate

Compare the incidence of bile leakage, cholangitis, phototoxicity and other complications between the two groups

Time frame
1, 2,3,4,5,6,7,8-week Post operation
3

Tumor-free margin length

Compare the length of the tumor-free margin of the two groups of cholangiocarcinoma tissues

Time frame
During operation

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: