S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

February 1, 2018 updated by: Yuhong Li

Phase II Study of Abraxane Plus S-1 as Second-line Treatment for Cholangiocarcinoma

This phase II study was designed to evaluate the efficacy and safety of S-1 plus Abraxane as second-line treatment for cholangiocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are no standard second-line treatment for cholangiocarcinoma, new therapies are needed. The efficacy of S-1 as first-line treatment for cholangiocarcinoma was confirmed in several studies. The IMPACT study showed that Abraxane plus gemcitabine provide better survival than gemcitabine alone. Since cholangiocarcinoma displayed similar sensitivity to chemotherapy which was used in pancreatic carcinoma, we assume that S-1 plus Abraxane is effective and safe in treating cholangiocarcinoma.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic or cytologic diagnosis of cholangiocarcinoma
  • Not eligible for curative surgery
  • Progressed after first-line gemcitabine-based chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
  • No serious or uncontrolled concomitant medical illness
  • Adequate bone marrow function (absolute neutrophil count ≧1,500 ul, platelet count ≧90,000/ul), hemoglobin: > or equal to 8 mg/dL, total bilirubin: < or equal to 1.5 X institutional upper limit of normal, calculated creatinine clearance greater than or equal to 60 mL/min (calculated by the Cockcroft and Gault method).

Exclusion Criteria:

  • Uncontrolled infection or severe active comorbid disease
  • Previous malignancy in the past five years, excluding nonmelanoma skin cancers and in situ cervical, bladder or uterine cancer
  • Pregnancy or lactating women

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-1 plus Abraxane
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
Drug: S-1 plus Abraxane
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
Other Names:
  • Paclitaxel Albumin-Bound Particles for Injectable Suspension
  • Gimeraciland Oteracil Porassium Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rates
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 6 months
6 months
Number of participants with adverse events
Time Frame: 12 months
Adverse events evaluated by Common Terminology Criteria for Adverse Events v3.0.
12 months

Collaborators and Investigators

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

Sponsor

Yuhong Li

Investigators

  • Principal Investigator: Yuhong Li, MD, Sun Yat-sen University

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

August 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 26, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1vsNab-P20130819

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.

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