Second Line Therapy in Advanced Biliary Tract Cancer
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2013-10-31, after 2011-11-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2013-10-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: chemotherapycancerconcurrentpriormetastatic
Phrases that lowered it: mm3hepatitisclinically significantsignificant diseasemg -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Drug's FAERS reports with a death: 27.6% (raises risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Design: parallel (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
-
Sponsor's past trials: 18 (raises risk) · Sponsor's track record
-
Maximum age: 75 (lowers risk) · Who can join
-
Collaborators: 1 (raises risk) · Design
-
Drug's FAERS reports before start: 15054 (raises risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 18 (typical: 32)
- Sponsor's past termination rate
- 11.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 15054 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2773 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, digestive
- Drugs matched to FDA substances
- capecitabine, mitomycin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Gemcitabine With/Out Capecitabine in Locally Advanced, Unresectable, or Metastatic Biliary Cancer NCT00658593 · started 2008 · scored riskier than 57% of active trials terminated
- A Randomized Study of GEMOX With or Without Cetuximab in Locally Advanced and Metastatic BTC NCT01267344 · started 2010 · scored riskier than 74% of active trials completed
- FOLFIRINOX for 2nd-line Treatment of BTC NCT03778593 · started 2019 · scored riskier than 65% of active trials completed
- Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers NCT00626158 · started 2008 · scored riskier than 97% of active trials completed
- Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer NCT03406299 · started 2018 · scored riskier than 88% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.