Chemothetapy FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
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|ClinicalTrials.gov Identifier: NCT03772132|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma of the Extrahepatic Bile Duct Gallbladder Cancer||Biological: mutation and signal pathway activation status analysis Drug: FORFIRINOX||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
The patients wil receive conventional chemotherapy FORFIRINOX
Biological: mutation and signal pathway activation status analysis Drug: FORFIRINOX
Conventional chemotherapy:5FU plus irinote- can plus oxaliplatin combination therapy
- Progression Free Survival [ Time Frame: 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.
- Overall survival [ Time Frame: up to 2 years ]
- Objective Response Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772132
|Contact: yingbin liu, PHD||+86 email@example.com|
|Shanghai, Shanghai, China, 200092|
|Contact: yingbin liu 13918803900 firstname.lastname@example.org|
|Principal Investigator:||yingbin liu, PHD||Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|