NCT03771846

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2018

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

4 years

First QC Date

December 9, 2018

Last Update Submit

December 3, 2019

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

intrahepatic cholangiocarcinomasystemic chemotherapyhepatic artery infusion chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    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.

    12 months

Secondary Outcomes (3)

  • Progression free survival

    12 months

  • Time to progression

    12 months

  • Number of adverse events.

    30 days

Study Arms (2)

Hepatic artery infusion chemotherapy

EXPERIMENTAL

Participants received hepatic artery infusion chemotherapy of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin

Drug: irinotecan, oxaliplatin , fluorouracil, and leucovorin

Systemic chemotherapy

ACTIVE COMPARATOR

Participants received systemic chemotherapy of gemcitabine and oxaliplatin

Drug: gemcitabine and oxaliplatin

Interventions

irinotecan, oxaliplatin , fluorouracil, and leucovorinDRUG

administration of irinotecan, oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Hepatic artery infusion chemotherapy
gemcitabine and oxaliplatinDRUG

administration of gemcitabine and oxaliplatin via vein

Systemic chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Ming Shi

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

IrinotecanOxaliplatinFluorouracilLeucovorinGemcitabine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesDeoxycytidineCytidinePyrimidine Nucleosides

Study Officials

  • Ming Shi, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Shi, MD

CONTACT

(8620)-87343938shiming@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

December 9, 2018

First Posted

December 11, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

CN(2)