Cholangiocarcinoma of the Bile Duct Clinical Trial
Official title:
Modified FOLFIRINOX Versus Gemcitabine Plus Oxaliplatin as First-line Chemotherapy for Patients With Locally Advanced or Metastatic Cholangiocarcinoma
| NCT number | NCT04305288 |
| Other study ID # | CCA20191021 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2016 |
| Est. completion date | December 2021 |
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
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 2021 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Xinhua Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Jiao Tong University School of Medicine |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Overall survival | up to 2 years | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |