A Phase 2 interventional study of Toripalimab and Gemcitabine in Advanced Cholangiocarcinoma, sponsored by Jiangmen Central Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-07-16.
Sponsored by Jiangmen Central Hospital · Phase 2, Interventional, and Treatment
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Jiangmen Central Hospital is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients were given Toripalimab 3 mg/kg (day 1 and 15); Gem+5-FU (Gem 1250mg/m2+CF 200 mg/m2+5-FU400 mg/m2 intravenous drip+5-FU 2.4-3.6 g/m2 continuous intravenous drip for 48 hours), the first and fifteenth days, four weeks for a cycle, a total of four cycles.After 4 cycles, Toripalimab was maintained at 3 mg/kg Q3 w for a total of 1 year if the disease was not progressing or toxic side effects were tolerated.
Drug: Toripalimab · Drug: Gemcitabine · Drug: 5- fluorine pyrimidine
3mg/kg on d1 and d15 q4W\*4cycles，then 3mg/kg q3w for 1 year in total
1250mg/m2 on d1 and d15 q4W\*4cycles
Also known as: Gem
400mg/m2 intravenous injection plus 5-FU 2.4g-3.6g/m2 continuous intravenous drip for 48h on d1 and d15 q4W\*4cycles
Also known as: 5-FU
6-month PFS rate
the rate of 6-month progression free survival
Time frame: 6-month after the beginning of first line systemic therapy
mPFS
the median of progression free survival
Time frame: from the beginning of the first line systemic therapy until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 24 months
Toxic side effects
assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0
Time frame: from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
ORR
the objective response rate
Time frame: from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
DCR
the disease control rate
Time frame: from the beginning of the first line systemic therapy until the date of completion of therapy,assessed up to 13 months
1-year OS rate
the rate of 1-year overall survival
Time frame: 1 year after the beginning of the first line systemic therapy
mOS
the median of overall survival
Time frame: from the beginning of the first line systemic therapy until the date of death from any cause,assessed up to 24 months
the value of PD-1/PD-L1
to analyze the predictive value of PD-1/PD-L1 for efficacy and toxicity
Time frame: from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
the value of MMR
to analyze the predictive value of MMR for efficacy and toxicity
Time frame: from the beginning of the first line systemic therapy until the end of follow-up,assessed up to 24 months
Plan to share: No
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jiangmen Central Hospital