Trial · NCT06371274
A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.
NCT06371274, Not applicable, Recruiting, First Affiliated Hospital of Zhejiang University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC. Trials, record NCT06371274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06371274
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.
- NCT number
- NCT06371274
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 29 participants, estimated
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Conditions
- Triple-negative Breast Cancer
- Interventions
- ATRA, Toripalimab
- First posted
- 2024-04-17
- Last updated
- 2025-08-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | up to 2 years | During the combined therapy, tumor assessment (enhanced CT) is conducted every 2 cycles (6 weeks), and the efficacy is evaluated using the RECIST 1.1 criteria. ORR will be summarized as the proportion of subjects achieving objective tumor responses (complete response or partial response). ORR and its 95% confidence interval will be calculated. |
| Secondary | Progression-Free Survival (PFS) | up to 2 years | PFS defined as the time from enrollment until disease progression or death (whichever occurs first). |
| Secondary | Duration of Response (DOR) | up to 2 years | For responders (complete response or partial response), DOR is defined as the time from the earliest date meeting the response criteria to disease progression or death for any reason (whichever occurs first). For subjects who do not experience progression after meeting response criteria and continue to survive, DOR will be censored at the last evaluable tumor assessment date or the last follow-up date for disease progression. |
| Secondary | Overall Survival (OS) | up to 2 years | OS is defined as the time interval between the date of the first dose and the date of death for any reason. Kaplan-Meier methodology will be used to estimate median OS, OS rates, and their 95% confidence intervals at different time points. |
| Other | Incidence of Treatment-Emergent Adverse events as assessed by NCI-CTCAE 5.0 | up to 2 years | Adverse events and toxicity will be assessed according to the NCI-CTCAE 5.0 criteria. Medical review of adverse events and laboratory values will be conducted, and a safety assessment will be completed. Adverse events occurring after treatment will be summarized based on preferred terms, organ system classification, NCI-CTCAE severity grading, and their relationship to the investigational therapy. Safety assessments will be conducted for all subjects receiving the study drug, with evaluation starting from the date of informed consent signing and continuing until the study concludes or 30 days after drug discontinuation. |
| Other | Exploratory biomarkers-peripheral blood lymphocyte analysis | start from the time of enrollment to the end of the study, assessed up to 2 years | Whole blood samples will be collected during the cycle 1 treatment period, defined as before the ATRA first dose (d0), d1, d2, d7 and d14. Later, the biological sample will also be provided before following each cycle treatment as only the subjects who have given informed consent and are willing to provide. Peripheral blood mononuclear cells (PBMCs) will be isolated and subjected to flow cytometry analysis using myeloid-derived suppressor cell (MDSC) and T lymphocyte molecular markers. Changes in the quantity, subsets, and surface markers of MDSC before and after treatment will be evaluated, and their relationship with the combined treatment response will be assessed. |
| Other | Exploratory biomarkers-Serum Metabolomics Analysis | start from the time of enrollment to the end of the study, assessed up to 2 years | Plasma samples will be collected during the cycle 1 treatment period, defined as before the ATRA first dose (d0), d1, d2, d7 and d14. Later, the biological sample will also be provided before following each cycle treatment as only the subjects who have given informed consent and are willing to provide. The Q300 metabolomics chip will be employed to quantitatively measure the concentrations of various metabolites. Data analysis will utilize correlation analysis methods (Pearson correlation) to assess the correlation between changes in metabolites and immune cell activity, as well as potential clinical efficacy, aiming to explore potential biomarkers for the combined treatment. |
| Other | Exploratory biomarkers-Fecal Microbiota Analysis | start from the time of enrollment to the end of the study, assessed up to 2 years | Fecal samples will be collected during the cycle 1 treatment period, defined as before the ATRA first dose (d0), d1, d7 and d14. Later, the biological sample will also be provided before following each cycle treatment as only the subjects who have given informed consent and are willing to provide. Classification and identification of the intestinal microbiota will be performed. Depending on the data type, chi-square tests, t-tests, or other non-parametric tests will be selected to compare differences between groups with different efficacy responses. |
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/NCT06371274
GET https://conductscience.org/api/trials/v1/NCT06371274/registered