Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors

NCT05220722 on ClinicalTrials.gov Phase 1/2 TriSalus Life Sciences, Inc. (industry) Started 2022-03-02 Terminated

Riskier than 67% of active trials

Model scores of the 29,894 trials active now.

Model score 19% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 29% of the time (655 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2024-07-31, after 2022-03-02 start.

Reason given by the sponsor: “enrollment”

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

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 2024-07-31. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: livercarcinomafunctionpriortumors
Phrases that lowered it: first doseaccordingpatients whomgpsoriasis
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1/2 (raises risk) · Design
Maximum age: 99 (lowers risk) · Who can join
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
Design: single group (raises risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 25.7% (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Number of arms: 1 (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 0 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 88.1% (raises risk) · Drug's FDA history
Responsible party: sponsor (lowers risk) · Design
Blinding: none (raises risk) · Design

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: 1/2 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 5 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 99 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 1 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 128083 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 22735 (typical: 412.5)
Drug's FAERS reports marked serious: 88.1% (typical: 85.6%)
Drug's FAERS reports with a death: 25.7% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, digestive
Drugs matched to FDA substances: ipilimumab, nivolumab, pembrolizumab

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

Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma NCT04935229 · started 2021 · scored riskier than 58% of active trials terminated
SELINEXOR in Combination w/Bevacizumab and Atezolizumab in Newly Diagnosed Advanced Hepatocellular Carcinoma NCT05093608 · started 2021 · scored riskier than 52% of active trials terminated
Hepatic Artery Infusion Chemotherapy (HAIC) Plus Durvalumab for Advanced Hepatocellular Carcinoma NCT04945720 · started 2022 · scored riskier than 60% of active trials completed
DYNAmic Immune Microenvironment of HCC Treated With atezolIzumab Plus bevaCizumab NCT04954339 · started 2021 · scored riskier than 77% of active trials completed
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma NCT03970616 · started 2019 · scored riskier than 93% of active trials terminated

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.