Neoadjuvant PDT in the Treatment of Cholangiocarcinoma

NCT04824742 | Not Yet Recruiting

• 1 other identifier: 2020ZDLSF04-08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma Resectable

Keywords

Cholangiocarcinoma,Neoadjuvant therapy,Photodynamic therapy

Outcome Measures

Primary Outcomes (3)

• R0 resection rate

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

  During operation

• Local recurrence rate

  Compare the local recurrence rate of cholangiocarcinoma between the two groups

  1-year post operation

• Survival time

  Compare the 5-year survival time of the two groups

  5-year post operation

Secondary Outcomes (3)

• Bilirubin level

  1,3,6,12-month post operation

• Complication rate

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

• Tumor-free margin length

  During operation

Study Arms (2)

neoadjuvant PDT + radical surgery

EXPERIMENTAL

Photodynamic therapy for neoadjuvant treatment of cholangiocarcinoma

Procedure: Neoadjuvant PDT + radical surgery

radical surgery

ACTIVE COMPARATOR

Patients with cholangiocarcinoma undergo radical surgical resection

Procedure: Radical surgery

Interventions

Neoadjuvant PDT + radical surgery PROCEDURE

Patients with cholangiocarcinoma will undergo radical surgery after photodynamic therapy

neoadjuvant PDT + radical surgery

Radical surgery PROCEDURE

Patients with cholangiocarcinoma will only receive radical surgery

radical surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

Yi Lv

Xi'an, Shaanxi, 710061, China

Location

Related Publications (2)

• Wiedmann M, Caca K, Berr F, Schiefke I, Tannapfel A, Wittekind C, Mossner 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. doi: 10.1002/cncr.11401.

  PMID: 12767091 BACKGROUND

• Wagner A, Wiedmann M, Tannapfel A, Mayr C, Kiesslich T, Wolkersdorfer 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.

  PMID: 26561801 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Yi Lv, MD,PHD

  China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Lv, MD,PHD

CONTACT

86-29-85323900; luyi169@126.com

Rongfeng Wang, MD

CONTACT

86-29-85324467; 15877553630@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)