Trial · NCT07003815
Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer
NCT07003815, Phase 2, Not yet recruiting, Tongji Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer. Trials, record NCT07003815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07003815
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Envafolimab With Chemotherapy and Simvastatin in Advanced Biliary Tract Cancer
- NCT number
- NCT07003815
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 62 participants, estimated
- Lead sponsor
- Tongji Hospital
- Conditions
- Biliary Tract Cancer, Advanced Cancer
- Interventions
- Envafolimab + Gemcitabine + Cisplatin + Simvastatin
- First posted
- 2025-06-04
- Last updated
- 2025-06-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) at 24 Weeks | From treatment initiation until 24 weeks (or disease progression, if earlier). | Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed by CT/MRI scans after 24 weeks of treatment. CR: disappearance of all target lesions; PR: ≥30% decrease in target lesion diameters. |
| Secondary | Progression-Free Survival (PFS) | Up to 2 years. | Time from treatment start to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 2 years. | Time from treatment start to death from any cause. |
| Secondary | Disease Control Rate (DCR) | Up to 2 years. | Proportion of participants with CR, PR, or stable disease (SD) lasting ≥12 weeks. |
| Secondary | Duration of Response (DOR) | Up to 2 years. | Time from first documented response (CR/PR) to disease progression or death. |
| Secondary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | From first dose until 30 days after last dose. | Frequency and severity of adverse events graded by CTCAE v5.0. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07003815
GET https://conductscience.org/api/trials/v1/NCT07003815/registered