Chemotherapy mFOLFIRINOX in Locally Advanced or Metastatic Cholangiocarcinoma

Modified FOLFIRINOX Versus Gemcitabine Plus Oxaliplatin as First-line Chemotherapy for Patients With Locally Advanced or Metastatic Cholangiocarcinoma

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 Overview

• Status: Unknown
• Conditions: Cholangiocarcinoma of the Bile Duct

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xinhua hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced or metastatic CCA.

Description

The inclusion criteria included: patients aged 18-70 years old, regardless of gender; patients with locally advanced or metastatic CCA diagnosed by imaging and pathology; modified FOLFIRINOX regimen or Gemox regimen as first-line treatment; ≥ 1 focus that can be evaluated by imaging examination.

Exclusion criteria included: incomplete clinical history data; suffering from other malignant tumors within 5 years, except basal cell carcinoma and cervical carcinoma in situ; having received other systemic chemotherapy, targeted therapy, immunotherapy or radiotherapy as first-line treatment; with severe organ dysfunction.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Gemox; The patients received conventional chemotherapy Gemox
mFOLFIRINOX; The patients received chemotherapy modified FOLFIRINOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	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.	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		up to 2 years
Disease Control Rate	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.	up to 1 year
Objective Response Rate	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.	up to 1 year
percentage of patients with Clinical Benefit Response	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.	up to 1 year

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• Zou L, Li X, Wu X, Cui J, Cui X, Song X, Ren T, Han X, Zhu Y, Li H, Wu W, Wang X, Gong W, Wang L, Li M, Lau WY, Liu Y. Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study. BMC Cancer. 2021 Jul 16;21(1):818. doi: 10.1186/s12885-021-08549-2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (ACTUAL): March 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: CCA20191021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No