Trial · NCT05048017
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | one year | A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause |
| Secondary | Objective Response Rate (ORR) | one year | Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients |
| Secondary | Complete response (CR) | one year | Disappearance of all target lesions, no appearance of new lesions, and normalization of tumor markers last for at least 4 weeks. |
| Secondary | Partial response (PR) | one year | Sum of the maximum diameters of target lesions is reduced by at least 30%, which lasts for at least 4 weeks. |
| Secondary | Overall survival (OS) | one year | It is the time from when a subject is clearly enrolled to death from any cause. |
| Secondary | Duration of response (DOR) | one year | It is the time from the first-time PR or CR (subject to the earlier one) objectively reported to the first-time disease progression or death. |
| Secondary | Percentage of patients with stable disease (SD) ≥ 4 weeks | one year | It is specifically referred to the percentage of patients with identified SD that can be evaluated for efficacy. |
| Secondary | Progression-free survival rate at 3 months | 6 months | It's the percentage of patients with no disease progression or died from any cause after 3 months of treatment with combination of regorafenib and PD-1 inhibitor in the total number of patients whose efficacy can be evaluated. |
| Secondary | Mortality at 12 months | one year and a half | It's the percentage of patients who died of any cause after 12 months treatment with combination of regorafenib and PD-1 inhibitor in total enrolled patients. |
| Other | Adverse Event (AE) | two years | Definition: Refers to any adverse medical event that occurs in patients receiving medical product treatment or subjects of clinical studies, which may not have a causal relationship with the treatment. AE includes but is not limited to: abnormal laboratory test results; clinically significant symptoms and signs; allergies, etc. |
| Other | Adverse Drug Reaction (ADR) | two years | All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase "responses to a medicinal products" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. |
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/NCT05048017/registered