Trial · NCT07360132
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | Up to approximately 24 Months | PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first) |
| Secondary | Overall Survival (OS) | Up to 24 Months | OS is defined as the period from the start of randomization to the time of death due to any cause according to RECIST 1.1. |
| Secondary | Objective Response Rate (ORR) | Up to 24 Months | ORR is defined as the proportion of subjects achieving the best overall therapeutic effect (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 by investigator. |
| Secondary | Disease control rate (DCR) | Up to 24 Months | DCR defined as the number of patients were confirmed CR and/or PR and/or stable disease(SD) according to RECIST 1.1 by investigator divided by the patients with at least one tumour evaluation |
| Secondary | Duration of response (DOR) | Up to 24 Months | DOR is defined as the time from the first record of CR or PR to the first record of disease. DOR as evaluated by investigators according to RECIST v1.1. |
| Secondary | Time to Progression(TTP) | Up to 24 Months | TTP is defined as the time from the time of randomization to the occurrence of disease progression according to recist 1.1 by investigator. |
| Secondary | Objective Response Rate (ORR)-BICR | Up to 24 Months | ORR is defined as the proportion of subjects achieving the best overall therapeutic effect (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 by BICR |
| Secondary | Disease control rate (DCR)-BICR | Up to 24 Months | DCR defined as the number of patients were confirmed CR and/or PR and/or stable disease(SD) according to RECIST 1.1 by BICR divided by the patients with at least one tumour evaluation |
| Secondary | Duration of response (DOR)-BICR | Up to 24 Months | DOR is defined as the time from the first record of CR or PR to the first record of disease. DOR as evaluated by BICR according to RECIST v1.1 |
| Secondary | Time to Progression(TTP)-BICR | Up to 24 Months | TTP is defined as the time from the time of randomization to the occurrence of disease progression according to recist 1.1 by BICR |
| Secondary | Safety Assement | Up to 24 Months | The incidence, severity and outcome of adverse events (AE), serious adverse events (SAE), immune-related adverse events (irAE) and adverse events of special concern (AESI) per NCI-CTCAE V5.0 |
| Secondary | Maximum serum concentration(Cmax) | Up to 24 Months | Cmax refers to The maximum blood concentration of HB0025 after administration. - Sample concentration analysis method adopts ELISA. parameters will be calculated by Phoenix WinNonlin version 8.3. |
| Secondary | Anti-drug antibodies (ADA) | Up to 24 Moths | Incidence of positive anti-drug antibodies(ADA). |
| Other | PD-L1 expression | Approximately 16 months. | Exploring the correlation between the levels of biomarkers (PD-L1) and the efficacy of combined treatment by Immunohistochemistry. |
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/NCT07360132/registered