Trials / Unknown
UnknownNCT03982680
Toripalimab Combined With Gemcitabine/5--fluoropyrimidine for Advanced Cholangiocarcinoma
Clinical Study of Toripalimab Monoclonal Antibody Combined With Gemcitabine/5--fluoropyrimidine in the Treatment of Advanced Cholangiocarcinoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Jiangmen Central Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The study is a phase II clinical trial of single arm. The purpose is to evaluate the safety and efficacy of anti-PD-1 antibody Toripalimab combined with chemotherapy(gemcitabine+5-fluorine pyrimidine) in unresectable advanced cholangiocarcinoma patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Toripalimab | 3mg/kg on d1 and d15 q4W\*4cycles，then 3mg/kg q3w for 1 year in total |
| DRUG | Gemcitabine | 1250mg/m2 on d1 and d15 q4W\*4cycles |
| DRUG | 5- fluorine pyrimidine | 400mg/m2 intravenous injection plus 5-FU 2.4g-3.6g/m2 continuous intravenous drip for 48h on d1 and d15 q4W\*4cycles |
Timeline
- Start date
- 2019-07-13
- Primary completion
- 2021-05-30
- Completion
- 2021-12-30
- First posted
- 2019-06-11
- Last updated
- 2019-07-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03982680. Inclusion in this directory is not an endorsement.