A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT07917481, Phase 2, Not yet recruiting, MedSIR
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma | ClinicalTrials.gov |
| NCT number | NCT07917481 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 44 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | MedSIR | ClinicalTrials.gov |
| Conditions | Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma (HCC) | ClinicalTrials.gov |
| Interventions | Ivonescimab | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | To demonstrate the efficacy of ivonescimab in terms of PFS in patients with advanced hepatocellular carcinoma. | From baseline up to 2 years. | PFS, defined as the period from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1. | ClinicalTrials.gov |
| Secondary | To demonstrate the efficacy of ivonescimab in terms of ORR in patients with advanced hepatocellular carcinoma. | From baseline up to 2 years. | ORR, defined as the rate of patients with complete response (CR) or partial response (PR), as determined locally by the investigator using RECIST v.1.1. | ClinicalTrials.gov |
| Secondary | To demonstrate the efficacy of ivonescimab in terms of DoR in patients with advanced hepatocellular carcinoma. | From baseline up to 2 years. | DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1. | ClinicalTrials.gov |
| Secondary | To demonstrate the efficacy of ivonescimab in terms of DCR in patients with advanced hepatocellular carcinoma. | From baseline up to 2 years. | DCR, defined as the rate of patients with objective response (CR or PR), or stable disease (SD), as determined locally by the investigator using RECIST v.1.1. | ClinicalTrials.gov |
| Secondary | To demonstrate the efficacy of ivonescimab in terms of OS in patients with advanced hepatocellular carcinoma. | From baseline up to 2 years. | OS, defined as the period from treatment initiation to death from any cause, as determined locally by the investigator. | ClinicalTrials.gov |
| Secondary | To describe disease-related symptoms and HRQoL as per EORTC 30-item QLQ-C30 and EORTC QLQ-HCC18. | From baseline up to 2 years. | Changes from baseline in the HRQoL as per EORTC 30-item QLQ-C30 and EORTC QLQ-HCC18 scale. All scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, and a high score for the global health status/QoL scale represents a high QoL, whereas a high score for the symptom scales and single items (including all QLQ-HCC18 scales and items) represents a high level of symptomatology or problems. | ClinicalTrials.gov |
| Secondary | To assess adverse events (AEs) between treatment groups in all patients. | From baseline up to 2 years. | Measures will include AEs and treatment-emergent AEs (TEAEs), including NCI CTCAE v6.0 severity grade and relationship to study drug. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)