S-1 in Combination With Abraxane in Treating Cholangiocarcinoma

NCT ID: NCT01963325

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-12-31

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.

Conditions

Cholangiocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

S-1 plus Abraxane

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Paclitaxel Albumin-Bound Particles for Injectable Suspension; Gimeraciland Oteracil Porassium Capsules

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhong Li

OTHER

Sponsor Role: lead

Responsible Party

Yuhong Li

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yuhong Li, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

S1vsNab-P20130819

Identifier Type: -

Identifier Source: org_study_id