Neoadjuvant PDT in the Treatment of Cholangiocarcinoma

Cholangiocarcinoma Resectable Clinical Trial

Official title:

A Prospective Randomized Controlled Study of Neoadjuvant PDT in the Treatment of Cholangiocarcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04824742
• Other study ID #: 2020ZDLSF04-08
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2028

Study information

• Verified date: March 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yi Lv, MD,PHD
• Phone: 86-29-85323900
• Email: luyi169[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Cholangiocarcinoma Resectable

Intervention

Procedure:
• Neoadjuvant PDT + radical surgery
Patients with cholangiocarcinoma will undergo radical surgery after photodynamic therapy
• Radical surgery
Patients with cholangiocarcinoma will only receive radical surgery

Locations

Country	Name	City	State
China	Yi Lv	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (2)

Wagner A, Wiedmann M, Tannapfel A, Mayr C, Kiesslich T, Wolkersdörfer GW, Berr F, Hauss J, Witzigmann H. Neoadjuvant Down-Sizing of Hilar Cholangiocarcinoma with Photodynamic Therapy--Long-Term Outcome of a Phase II Pilot Study. Int J Mol Sci. 2015 Nov 6;16(11):26619-28. doi: 10.3390/ijms161125978. — View Citation

Wiedmann M, Caca K, Berr F, Schiefke I, Tannapfel A, Wittekind C, Mössner J, Hauss J, Witzigmann H. Neoadjuvant photodynamic therapy as a new approach to treating hilar cholangiocarcinoma: a phase II pilot study. Cancer. 2003 Jun 1;97(11):2783-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	Compare the incidence of positive margins of bile duct after surgical resection of cholangiocarcinoma between the two groups	During operation
Primary	Local recurrence rate	Compare the local recurrence rate of cholangiocarcinoma between the two groups	1-year post operation
Primary	Survival time	Compare the 5-year survival time of the two groups	5-year post operation
Secondary	Bilirubin level	Compare the Bilirubin level of the two groups	1,3,6,12-month post operation
Secondary	Complication rate	Compare the incidence of bile leakage, cholangitis, phototoxicity and other complications between the two groups	1, 2,3,4,5,6,7,8-week Post operation
Secondary	Tumor-free margin length	Compare the length of the tumor-free margin of the two groups of cholangiocarcinoma tissues	During operation