Trial · NCT07339488
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 1-Year Progression-Free Survival Rate (1y-PFSR) | Up to 12 months after the initiation of treatment. | The 1y-PFSR is defined as the proportion of patients who remain alive without documented cancer progression 1 year after the initiation of treatment. |
| Secondary | Pathological Complete Response (pCR) Rate | From postoperative day 0 up to 15 weeks postoperatively. | The proportion of patients who, following conversion therapy, exhibit no residual invasive cancer cells in either the primary tumor site or regional lymph nodes upon pathological evaluation of surgical resection specimens, expressed as a percentage of the total treated population. |
| Secondary | Objective Response Rate (ORR) | Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months. | Proportion of patients achieving complete response (CR) or partial response (PR) (sustained ≥4 weeks) per RECIST v1.1 and iRECIST criteria. |
| Secondary | Major Pathological Response (MPR) Rate | From postoperative day 0 up to 15 weeks postoperatively. | MPR is defined as the proportion of patients with ≤10% residual viable tumor cells in surgical specimens following treatment. Pathological evaluation requires standardized sampling and separate assessment of lymph node metastases. |
| Secondary | Disease Control Rate (DCR) | Baseline, every 6 weeks during conversion therapy, postoperation, every 4 months following the first postoperative assessment with a maximum duration of 12 months. | DCR is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) post-treatment, as measured by RECIST 1.1 and iRECIST criteria. |
| Secondary | Adverse Event Incidence Rate | Up to 12 months after surgery. | The proportion of patients experiencing adverse events of any grade (graded according to CTCAE 6.0, Common Terminology Criteria for Adverse Events, grades 1-5) during treatment. |
| Secondary | 1-Year Overall Survival Rate (1y-OSR) | Up to 12 months after the initiation of treatment. | The 1y-OSR is defined as the proportion of patients who have not experienced all-cause death at 12 months following the initiation of treatment. |
| Secondary | Surgical Conversion Rate | Up to 12 months after surgery. | Defined as the proportion of initially unresectable patients who are converted to resectable status following treatment. |
| Secondary | R0 Resection Rate | From postoperative day 0 up to 15 weeks postoperatively. | Defined as the proportion of radical surgeries achieving microscopically negative margins (margin ≥1 mm). |
| Other | Peripheral Blood Immune Landscape | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | Flow cytometry analysis is performed on peripheral blood samples. |
| Other | Peripheral Blood Transcriptomics | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | RNA sequencing is performed on peripheral blood samples. |
| Other | Peripheral Blood Immune Receptor Repertoire | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | TCR sequencing is performed on peripheral blood samples. |
| Other | Serum Metabolomics | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | The wide arrays of metabolites in peripheral blood samples are analyzed qualitatively and quantitatively. |
| Other | Serum Cytokine Analysis | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | The wide arrays of cytokines in peripheral blood samples are analyzed qualitatively and quantitatively. |
| Other | Tissue Transcriptomics | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | RNA sequencing is performed on tissue samples. |
| Other | Tissue Immune Receptor Repertoire | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | TCR sequencing is performed on tissue samples. |
| Other | Tissue Immunohistochemistry | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | Multi-marker fluorescent immunohistochemistry is performed on tissue samples. |
| Other | Changes of Intestinal Flora | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | Fecal samples are analyzed by metagenomics sequencing. |
| Other | Fecal Metabolomics | Baseline, and at a follow-up time point within 6 weeks after completion of conversion therapy but before surgical resection. | The wide arrays of metabolites in fecal samples are analyzed qualitatively and quantitatively. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07339488/registered