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Chemotherapy FOLFIRINOX in Advanced or Recurrent Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04305288
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Yingbin Liu, MD, PhD, FACS, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The purpose of this study is to evaluate the feasibility, efficacy and safety of FOLFIRINOX in advanced or recurrent cholangiocarcinoma

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma of the Bile Duct Drug: FOLFIRINOX Conventional chemotherapy Phase 2

Detailed Description:
The purpose of this study is to evaluate the feasibility, efficacy and safety of FOLFIRINOX in advanced or recurrent cholangiocarcinoma

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-center, Open-label, Randomised, Controlled Study of FOLFIRINOX in Advanced or Recurrent Cholangiocarcinoma
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chemotherapy
The patients wil receive conventional chemotherapy FOLFIRINOX
Drug: FOLFIRINOX Conventional chemotherapy
5FU plus irinotecan plus oxaliplatin plus folinic acid combination therapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 2 years ]
  2. 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.

  3. 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.

  4. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chinese;
  • Stable vital signs, KPS≥70;
  • Patients have a diagnosis of advanced or recurrent metastatic cholangiocarcinoma by histopathology or cytopathology;、 visceral measurable metastases (at least one lesion>10 mm) and/or measurable and non-resectable primary tumor.
  • Life expectancy of more than 12 weeks;
  • Adequate hepatic, hematologic and renal functions(ALT≤10×upper limit of normal (ULN), AST≤10×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10^9/L, neutrophils≥1.5×10^9/ L, platelets≥75×10^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min,Prothrombin rate ≥70%;
  • Volunteer for this study, have written informed consent and have good Patient compliance;

Exclusion Criteria:

  • Recived Anti-tumor molecular target therapy; anti-tumor chemotherapy in 4 months; lesions have been treated by irradiation; participate in other therapeutic or interventional clinical trials.
  • Have central nervous system metastasis;
  • History of other malignancies;
  • Have symptomatic ascites and need for treatment;
  • Have serious concurrent illness including, but not limited to

    1. uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure >21.3 Kpa or diastolic blood pressure >13.3 Kpa);
    2. ongoing or active serious infection;
    3. uncontrolled diabetes mellitus;
    4. psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
    5. HIV infection;
    6. other serious illness considered not suitable for this study by investigators.
  • be allergic or have contraindications to target medicines involved in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04305288


Contacts
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Contact: yingbin liu, PHD +86 13918803900 laoniulyb@163.com

Locations
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China, Shanghai
Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: yingbin liu    13918803900    laoniulyb@163.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: yingbin liu, PHD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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Responsible Party: Yingbin Liu, MD, PhD, FACS, head of general surgery department,xin hua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04305288    
Other Study ID Numbers: CCA20191021
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Folfirinox
Antineoplastic Agents