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HAIC Versus Systemic Chemotherapy for Unresectable ICC

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ClinicalTrials.gov Identifier: NCT03771846
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Shi Ming, Sun Yat-sen University

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of gemcitabine, oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Drug: gemcitabine, oxaliplatin , fluorouracil, and leucovorin Drug: gemcitabine and oxaliplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Arterial Infusion Chemotherapy of Gemcitabine, Oxaliplatin, 5-Fluorouracil and Leucovorin Versus Systemic Chemotherapy of Gemcitabine and Oxaliplatin for Unresectable Intrahepatic Cholangiocarcinoma
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022


Arm Intervention/treatment
Experimental: Hepatic artery infusion chemotherapy
Participants received hepatic artery infusion chemotherapy of gemcitabine, oxaliplatin, 5-fluorouracil and leucovorin
Drug: gemcitabine, oxaliplatin , fluorouracil, and leucovorin
administration of gemcitabine, oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Active Comparator: Systemic chemotherapy
Participants received systemic chemotherapy of gemcitabine and oxaliplatin
Drug: gemcitabine and oxaliplatin
administration of gemcitabine and oxaliplatin via vein




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months ]
    OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 12 months ]
    PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.

  2. Time to progression [ Time Frame: 12 months ]
    TTP was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST).

  3. Number of adverse events. [ Time Frame: 30 days ]
    Postoperative adverse events were graded based on CTCAE v4.03



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The diagnosis of ICC
  • Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
  • With no previous treatment
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
  • Without distant metastasis, but intrahepatic lymph node metastasis is allowed
  • The following laboratory parameters:

Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3

Exclusion Criteria:

  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
  • Known history of HIV
  • History of organ allograft
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Known central nervous system tumors including metastatic brain disease

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): NCT03771846


Contacts
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Contact: Ming Shi, MD (8620)-87343938 shiming@sysucc.org.cn

Locations
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China, Guangdong
Cancer Center Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ming Shi, MD    8620-87343115    shiming@mail.sysu.edu.cn   
Ming Shi Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ming Shi, MD    (8620)-87343938    shiming@sysucc.org.cn   
Sponsors and Collaborators
Shi Ming
Investigators
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Principal Investigator: Ming Shi, MD Sun Yat-sen University

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Responsible Party: Shi Ming, Proffessor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03771846     History of Changes
Other Study ID Numbers: S035
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shi Ming, Sun Yat-sen University:
intrahepatic cholangiocarcinoma
systemic chemotherapy
hepatic artery infusion chemotherapy
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Fluorouracil
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs