The outcome of gemcitabine, sorafenib and S1 combination in the treatment of inoperable hilar cholangiocarcinoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-14004737

Enrollment

Unknown

Registered

2014-03-31

Start date

2014-06-08

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Hilar cholangiocarcinoma

Interventions

Gemcitable alone:Intravenously at a dose of 1000 mg/m2 on days 1, 8, and 15 of each 4-week cycle

Gemcitable+S1 group:Gemcitabine intravenously at 1000 mg/m2 on days 1

Gemcitable+S1 +Sorafenib group:Gemcitabine 1000 mg m(-2) and S1 on a 2 weeks on/1 week off cycle and sorafenib 400mg twice daily

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Hilar cholangiocarcinoma diagnosed by pathological examination or typical radiographic findings; 2. Unresectable locally advanced or metastatic disease; 3. No prior treatment for hilar cholangiocarcinoma includign surgery or radiation therapy; 4. Age>18 years; 5. To be able to oral intake the chemotherapy drugs.

Exclusion criteria

Exclusion criteria: 1. Severe complications, such as active infection, cardiac or renal disease, marked pleural effusion, or ascites; 2. Active gastrointeatinal bleeing; 3. Severe drug hypersensitivity; 4. Active concomitant malignancy; and 5. Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
Leukocytes;	—

Countries

China

Contacts

Public ContactGuangwen Zhou

Shanghai Jiao Tong University School of Medicine

gwzhousfph@163.com+86 13916662683

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026