Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer

Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer - Continuous administration trial of Phase2 Study of OTS102 in Combination With Gemcitabine in Patients With Unresectable Advanced Biliary Tract Cancer and recurrent Biliary Tract Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006436

Enrollment

Registered

2011-10-01

Start date

2011-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Unresectable Advanced and Recurrent Biliary Tract Cancer

Interventions

OTS102 1mL will be administered by subcutaneous injection on days,1,8,15 and 22 of each 28-day treatment cycles. Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days,1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who are administering OTS102 in Study202. 2) Patients who wish to continue to use of OTS102 and GEM, there is no obvious underlying disease progression, and there is the clinical benefit in patients by continued use of OTS102 and GEM. 3) ECOG Performance Status musut be 0 to 2. 4) Voluntarily signed the written consent form.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026