Clinical Feasibility of Nab-paclitaxel Plus Gemcitabine-cisplatin Chemotherapy in Locally Advanced Cholangiocarcinoma

February 5, 2024 updated by: CHA University

Clinical Feasibility of Nab-paclitaxel Plus Gemcitabine-cisplatin Chemotherapy in Patients With Locally Advanced Cholangiocarcinoma and Discovery of Biomarkers

The objective of this observational study is to identify patients with locally advanced cholangiocarcinoma treated with nab-paclitaxel and gemcitabine-cisplatin chemotherapy.

In this clinical study, peripheral blood and tumor tissues will be analyzed at baseline and every 3 cycles after systemic drug treatment in patients with locally advanced cholangiocarcinoma, and correlation with treatment was analyzed. This is an exploratory study to discover biomarkers that are highly correlated with treatment response.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Although surgical treatment is the only treatment for cholangiocarcinoma, most patients are diagnosed at a metastatic or locally advanced stage, and palliative chemotherapy is the main treatment method for this group of patients.

Recently, with the introduction of gemcitabine, cisplatin, and nab-paclitaxel combination chemotherapy for locally advanced cholangiocarcinoma, the treatment response rate is improving, and the number of cases of downgrade to an operable state is increasing.

However, there are no prospective studies confirming the rate of conversion surgery after gemcitabine, cisplatin, and Nab-paclitaxel combination therapy in locally advanced cholangiocarcinoma. As a result of long-term follow-up, more than 30% of patients relapsed, so it is urgent to develop predictive biomarkers before surgery.

There are reports that tumor DNA (ctDNA) accurately predicts recurrence after surgical treatment. Using blood samples that are relatively easy to collect compared to biopsies, it is possible to quantitatively measure tumor burden and to evaluate the effectiveness of systemic treatments such as chemotherapy. It is a very popular tool for measuring and predicting the success of surgical treatment in advanced solid cancer.

The purpose of this study was to determine the rate of conversion surgery after treatment with Gemcitabine, Cisplatin, and Nab-paclitaxel in patients with inoperable locally advanced cholangiocarcinoma through an observational study. In addition, the purpose of this study is to verify the performance of biomarkers in predicting recurrence and survival after ctDNA and RNA conversion surgery in a situation where there is no clinical strategy to select a group of patients who can try radical resection.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Recruitment of advanced cholangiocarcinoma patients through a competitive registration process at CHA Bundang Hospital, Haeundae Paik Hospital, and Seoul National University Bundang Hospital.

Description

Inclusion Criteria:

  • Those above the age of 19 who understand the purpose of the study and agree to participate in the collection of samples during the study.
  • Patients with histologically or cytologically confirmed inoperable locally advanced cholangiocarcinoma (gallbladder cancer, extrahepatic biliary tract cancer, intrahepatic biliary tract cancer)
  • Patients who underwent an NGS test with advanced cholangiocarcinoma tissues
  • Patients planning to be treated with nab-paclitaxel plus gemcitabine-cisplatin combination therapy
  • ECOG performance status 0 or 1

Exclusion Criteria:

  • Systemic condition accompanied by instability of vital signs such as infection or organ failure
  • Patients who have previously received palliative chemotherapy for cholangiocarcinoma
  • Those with mental/neurological conditions or dementia who have difficulties understanding and completing the consent form
  • Those who are assessed as not suitable for this study, at the discretion of the researcher

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
nab-paclitaxel plus gemcitabine-cisplatin
gemcitabine, 800 mg/m2, cisplatin, 25 mg/m2, and nab-paclitaxel, 100 mg/m2, on days 1 and 8 of 21-day cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion Surgery Rate
Time Frame: 6 months
Proportion of patients who underwent conversion surgery
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 2 years

Overall survival is calculated as the time from initiation of treatment until death.

The follow-up period is from initiation of treatment until the date of death or for 1 year after last patient enrollment, whichever is earlier.
2 years
ORR
Time Frame: 1 year

Overall Response Rate follow-up will be conducted every 6 weeks. Lesion will be evaluated according to RECIST 1.1 (CR, complete disappearance or LN short axis diameter < 1.0cm; PR, ≥30% reduction; PD, ≥20% increase; SD, neither CR, PR nor PD).

The follow-up period is from initiation of treatment until date of disease progression or death or for 1 year after last patient enrollment, whichever is earlier.
1 year
PFS
Time Frame: 2 years

Progression Free Survival is calculated as the time from initiation of treatment until the date of disease progression or death without PD.

The follow-up period is from initiation of treatment until the date of disease progression or death without PD or for 1 year after last patient enrollment, whichever is earlier.

Each time ORR is measured at 2-month intervals, progression-free survival will be checked.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Rate
Time Frame: through study completion, an average of 1 year
Rate of recurrence after conversion surgery
through study completion, an average of 1 year
Change of ctDNA
Time Frame: From baseline to 1 year of treatment
The concentration of circulating DNA(ctDNA) in blood samples from patients with cholangiocarcinoma.
From baseline to 1 year of treatment
Identification of potential Biomarkers of Conversion Surgery
Time Frame: From baseline to 1 year of treatment
Analysis of the expression patterns of immune-related proteins in tissue/blood samples collected in this study to identify biomarkers related to conversion surgery
From baseline to 1 year of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHA University

Investigators

  • Principal Investigator: Hong Jae Chon, MD,PhD, CHA Bundang Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-11-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Locally Advanced Cholangiocarcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe