Neoadjuvant GCS therapy for locally advanced perihilar cholangiocarcinoma

JRCT ID: jRCTs041210063

Registered date:02/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Locally advanced perihilar cholangiocarcinoma
• Date of first enrollment: 06/09/2021
• Target sample size: 25
• Study type: Interventional

Intervention(s)

Neoadjuvant cgemotherapy using GCS (combination of gemcitabine, cysplatin and S-1) is performed.
Patients receive 4 courses of following regimen: infusion of gemcitabine at a dose of 1000 mg/m2 and cisplatin 25mg/m2 on days 1, and orally S-1 twice daily at a dose of 80mg/m2/day on days 1 through 7 of a 14-day cycle.

Outcome(s)

Primary Outcome

The rate of high responder cases after GCS therapy to all eligible cases

High responder: the percentage of viable carcinoma in the tumor bed is less than 30%.
Low responder: the percentage of viable carcinoma in the tumor bed 30% or higher.

• Secondary Outcome: Complete treatment rate, radiographic response rate, curative-intent resection rate, degree of residual tumor, 2-year and 5-year overall survival rate, postiopeative complication rate, recurrence rate after surgery and mode of recurrence.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1. Person who is 20 years old or more but less than 80.
2. Person newely diagnosed as perihilar cholangiocarcinoma by imaging study and histological or cytological study.
3. Person without distant metastasis
4. Person diagnosed as resectable or borderline resectable cancer by contrast enhanced multidetector CT imaging.
5. Person who is toleable for curative resection
6. Person without previous anti-tumor treatments
7. Person whose Eastern Cooperative Oncology Group performance status is 0 or 1
8. Person with adequate hematological, hepatic, renal, and cardiopulmonary functions
9. Person who is capable of adequate oral intake
10. Person who gave written informed consent to be enrolled in the study
11. Person with enough ability to decide to participate in the study

Exclude criteria

Patients who:
1) is allergic to the chemotherapeutic agents.
2) has pulmonary fibrosis or intestinal pneumonia.
3) has active infectious disease.
4) has simulatenous active cancer.
5) is pregnant or possibly pregnant.
6) is defined as inapproriate to be enrolled in the clinical trial by a principal investigator or subinvestigators.

Related Information

• Primary Sponsor: Mizuno Shugo