Trial · NCT07109401
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | One-year Event-free Survival Rate (1-year EFS Rate) | Up to 12 months | The proportion of patients who have not experienced an EFS event within 1 year after the first administration of the study drug. EFS (Event-Free Survival) is defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first). EFS is assessed by investigators based on RECIST v1.1 (Response evaluation criteria in solid tumors v1.1) criteria within the radical curative therapy analysis set. |
| Secondary | Event-free Survival (EFS) | up to 60 months | Event-Free Survival (EFS) - defined as the time from the first dose of study treatment until the first occurrence of any of the following events: objectively documented disease progression and inability to undergo radical surgery, local recurrence, distant metastasis, or death from any cause (whichever occurs first). |
| Secondary | Overall Survival (OS) | up to 60 months | Overall Survival - defined as the time from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. |
| Secondary | Objective Response Rate (ORR) | Up to 12 months | Objective Response Rate (ORR) - defined as the proportion of patients who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by investigators according to RECIST v1.1 criteria. |
| Secondary | Disease Control Rate (DCR) | Up to 12 months | Disease Control Rate (DCR) - defined as the proportion of patients who achieve a Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), or Stable Disease (SD), as assessed by investigators according to RECIST v1.1 criteria. |
| Secondary | Pathological Complete Response (pCR) Rate | Up to 12 months | Pathological Complete Response (pCR) Rate - defined as the proportion of patients who have no residual tumor in the resected primary tumor site and all resected lymph nodes after neoadjuvant therapy among those who underwent surgical resection. |
| Secondary | Major Pathological Response (MPR) Rate | Up to 12 months | Major Pathological Response (MPR) Rate - defined as the proportion of patients who have ≤10% residual viable tumor cells in the resected primary tumor site and all resected lymph nodes after neoadjuvant therapy among those who underwent surgical resection. |
| Secondary | Pathological Downstaging Rate | Up to 12 months | Pathological Downstaging Rate - defined as the proportion of patients who undergo surgical resection after neoadjuvant therapy and have a postoperative pathological stage that is lower than their baseline clinical tumor stage and/or lymph node involvement. |
| Secondary | R0 Resection Rate | Up to 12 months | R0 Resection Rate - defined as the proportion of patients who achieve complete tumor resection (negative margins with no residual tumor cells) among those who underwent surgical resection after neoadjuvant therapy. |
| Secondary | Clinical Downstaging Rate | Up to 12 months | Clinical Downstaging Rate - defined as the proportion of patients who have a reduction in tumor size and/or lymph node involvement in their clinical tumor stage after neoadjuvant therapy compared to their baseline clinical tumor stage before surgery. |
| Secondary | Surgical Resection Rate | Up to 12 months | Surgical Resection Rate - defined as the proportion of patients who undergo surgical resection after neoadjuvant therapy. |
| Secondary | Incidence of Treatment-emergent Adverse Event (TEAE) and Immune-related Adverse Event (IrAE) | Up to 60 months | The incidence of TEAE and IrAE will be assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, and by incorporating relevant physical examinations, electrocardiograms (ECGs), and laboratory tests as needed. |
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/NCT07109401/registered