An observational study in Cholangiocarcinoma of the Bile Duct, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Shanghai Jiao Tong University School of Medicine · Observational
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
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
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 100 is below the median of 196 across 176 observational studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
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Patients with locally advanced or metastatic CCA.
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.
The patients received conventional chemotherapy Gemox
The patients received chemotherapy modified FOLFIRINOX
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
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
Plan to share: Undecided
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine