Trial · NCT07913360
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | Up to approximately 2 years | Progression-free survival (PFS) assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
| Primary | Overall survival（OS） | Up to approximately three and a half years | Overall survival |
| Secondary | Progression-free survival (PFS) assessed by the investigator | Up to approximately 2 years | PFS assessed by the investigator according to RECIST v1.1 |
| Secondary | Objective response rate (ORR) | Up to approximately three and a half years | Objective response rate (ORR) assessed by BICR and the investigator according to RECIST v1.1 |
| Secondary | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Up to approximately three and a half years | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v6.0 |
| Secondary | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) leading to treatment modifications | Up to approximately three and a half years | Incidence and severity of AEs/SAEs leading to treatment discontinuation, treatment interruption, and dose reduction |
| Secondary | Changes in scores assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | Up to approximately three and a half years | The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms. |
| Secondary | Peak Plasma concentration (Cmax) of GFH375 | Up to approximately three and a half years | Peak Plasma concentration (Cmax) of GFH375 following combination treatment |
| Secondary | Disease control rate (DCR) | Up to approximately three and a half years | Disease control rate (DCR) assessed by BICR and the investigator according to RECIST v1.1 |
| Secondary | Time to response (TTR) | Up to approximately three and a half years | Time to response (TTR) assessed by BICR and the investigator according to RECIST v1.1 |
| Secondary | Duration of response (DoR) | Up to approximately three and a half years | Duration of response (DoR) assessed by BICR and the investigator according to RECIST v1.1 |
| Secondary | Changes in scores assessed by the EORTC Colorectal Cancer-Specific Quality of Life Questionnaire 29 (EORTC QLQ-CR29) | Up to approximately three and a half years | The EORTC QLQ-CR29 is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. It incorporates 4 multiitem scales and 19 single-items assessing a range of symptoms and problems common among patients with colorectal cancer. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems. |
| Secondary | Trough Plasma concentration (Ctrough) of GFH375 | Up to approximately three and a half years | Trough Plasma concentration (Ctrough) of GFH375 following combination treatment |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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