S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01963325

Enrollment

Registered

2013-10-16

Start date

2013-08-31

Completion date

2017-12-31

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Brief summary

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

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.

Interventions

DRUGS-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rates	6 months

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026