Trial · NCT05713994
Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma
NCT05713994, Recruiting, Ze-yang Ding, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma. Trials, record NCT05713994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05713994
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined HAIC, TKI/Anti-VEGF and ICIs as Conversion Therapy for Unresectable Hepatocellular Carcinoma
- NCT number
- NCT05713994
- Status
- Recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Ze-yang Ding, MD
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Interventions
- HAIC, Bevacizumab plus Atezolizumab, Bevacizumab Biosimilar IBI305 plus sintilimab, Lenvatinib, Sorafenib, Donafenib, Regorafenib, apatinib plus camrelizumab, Anti-PD-1 monoclonal antibody
- First posted
- 2023-02-06
- Last updated
- 2025-03-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Amendable to Curative Surgical Interventions | from the date of first treatment to the date of last treatment, an average of 3 years | Number of patients amendable to curative surgical interventions defined as number of patients receiving curative surgical resection, transplantation, or ablation after successful down-sizing of tumor(s) by intervention. |
| Secondary | overall response rate (ORR) measured by mRECIST criteria | rom the date of first treatment to radiographically documented progression according to mRECIST, assessed up to 3 years | Complete response (CR): Disappearance of any intra-tumoral arterial enhancement in all target lesions; Partial response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions; Stable disease (SD): Any cases that do not qualify for either partial response or progressive disease; Progressive disease (PD): An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. ORR=CR+PR. |
| Secondary | Time to progression (TTP) | from the date of first treatment to radiographically documented progression according to mRECIST, assessed up to 3 years | Time to progression (TTP): measured from the date of first treatment to radiographically documented progression according to mRECIST 1.1. This does not include death from any cause. |
| Secondary | Time to intrahepatic tumor progression (TTITP) | from the date of first treatment to radiographically documented intrahepatic tumor progression according to mRECIST, assessed up to 3 years | Time to intrahepatic tumor progression (TTITP): measured from the date of first treatment to radiographically documented intrahepatic tumor progression according to mRECIST 1.1. This does not include death from any cause. |
| Secondary | Progression-free survival (PFS) | from the date of first treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause, whichever occurs first, assessed up to 3 years | measured from the date of first treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment. |
| Secondary | Overall survival (OS) | from the date of first treatment to the date of death from any cause, assessed up to 5 years | Overall survival (OS): measured from date of first treatment to the date of death from any cause. Participants alive or lost to follow-up will be censored at the date of their last visit. |
| Secondary | Incidence of Study-Related Adverse Events | from the date of first treatment to 90 days after last treatment, around 3 years and 90 days | Incidence, nature, and severity of adverse events graded according to the United States National Cancer Institute The Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) |
| Secondary | Pathological response | from the date of first study treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause, whichever occurs first, assessed up to 5 years | Pathological response is assessed as the percentage of surface with non-viable cancer cells (represented by necrosis or fibrosis, the ultimate stage of necrosis) in relation to the total tumor area and will be equal to: 100% - viable cancer cells (%). If there are multiple tumors, the mean percentage will be used. |
| Secondary | Disease control rate (DCR) | from the date of first treatment to radiographically documented response according to mRECIST, assessed up to 3 years | Percentage of patients that had a CR, PR, or SD ≥ 6 months per mRECIST |
| Secondary | Duration of response | from the date of first documented evidence of CR or PR to first documented sign of PD or death from any cause according to mRECIST 1.1, assessed up to 3 years | Defined as the time from first documented evidence of CR or PR until the first documented sign of disease progression (PD) or death from any cause |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05713994
GET https://conductscience.org/api/trials/v1/NCT05713994/registered