Chemotherapy mFOLFIRINOX in Locally Advanced or Metastatic Cholangiocarcinoma

Shanghai Jiao Tong University School of Medicine100 enrolled

Overview

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

100

Conditions

Cholangiocarcinoma of the Bile Duct

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xinhua Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: up to 1 year

Secondary Outcomes

Overall survival

Time frame: up to 2 years

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.

Time frame: up to 1 year

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.

Time frame: 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.

Time frame: up to 1 year

Central Contacts

yingbin liu, PHD

CONTACT

+86 13918803900 laoniulyb@163.com

Data from ClinicalTrials.gov

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