Chemotherapy mFOLFIRINOX in Locally Advanced or Metastatic Cholangiocarcinoma

• Conditions: Cholangiocarcinoma of the Bile Duct

• Registration Number: NCT04305288
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA

Detailed Description

The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-12
• Status Verified: 2020-12
• Primary Completion: 2020-12
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2021-01-05
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	up to 1 year	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 2 years
Objective Response Rate	up to 1 year	Objective Response Rate is defined as the percentage of patients with a complete or partial response to treatment,consistent with RECIST version 1.1 criteria for solid tumors.
Disease Control Rate	up to 1 year	Disease Control Rate is defined as the percentage of patients with a complete or partial response to treatment or stable disease, consistent with RECIST version 1.1 criteria for solid tumors.
percentage of patients with Clinical Benefit Response	up to 1 year	Composite measure based on patient-reported pain (per Faces pain scale revised), patient-reported pain medication, Karnofsky performance status(KPS), and weight. Clinical benefit is indicated by either:(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.; Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China