NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC
NCT07919717, Phase 2, Not yet recruiting, Shanghai Zhongshan Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC | ClinicalTrials.gov |
| NCT number | NCT07919717 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 35 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Shanghai Zhongshan Hospital | ClinicalTrials.gov |
| Conditions | Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer | ClinicalTrials.gov |
| Interventions | Nivolumab, Ipilimumab, Repeat Hepatectomy | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Major Pathological Response (MPR) Rate | Day 43 through Day 90 after the first dose | Percentage of participants who achieve major pathological response, defined as 50% or less residual viable tumor cells in the tumor bed, as determined by pathological assessment of the repeat hepatectomy specimen. | ClinicalTrials.gov |
| Secondary | Pathological Complete Response (pCR) Rate | Day 43 through Day 90 after the first dose | Percentage of participants who achieve pathological complete response, defined as no residual viable tumor cells in the tumor bed, as determined by pathological assessment of the repeat hepatectomy specimen. | ClinicalTrials.gov |
| Secondary | Preoperative Objective Response Rate (ORR) According to RECIST Version 1.1 | From baseline through the preoperative tumor assessment on Day 43 (±3 days) after the first dose | Percentage of participants with a best overall response of complete response or partial response before repeat hepatectomy, as assessed by the investigator according to RECIST version 1.1. | ClinicalTrials.gov |
| Secondary | Preoperative Objective Response Rate (ORR) According to Modified RECIST (mRECIST) | From baseline through the preoperative tumor assessment on Day 43 (±3 days) after the first dose | Percentage of participants with a best overall response of complete response or partial response before repeat hepatectomy, based on assessment of viable hepatocellular carcinoma according to mRECIST. | ClinicalTrials.gov |
| Secondary | Recurrence-Free Survival (RFS) | From repeat hepatectomy until recurrence or death, assessed every 12 weeks (±7 days) for up to 2 years after surgery | Time from completion of repeat hepatectomy to the first documented recurrence confirmed by imaging or histology, or death from any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | From study entry until death from any cause, assessed every 3 months (±7 days) for up to 5 years | Time from study entry to death from any cause. | ClinicalTrials.gov |
| Secondary | Incidence of Adverse Events and Serious Adverse Events | From the first dose through 30 days (±7 days) after the later of completion of neoadjuvant therapy or repeat hepatectomy | Percentage of treated participants who experience adverse events, serious adverse events, immune-mediated adverse events, treatment-related adverse events, deaths, or clinically significant laboratory abnormalities. Event severity will be graded according to NCI CTCAE version 6.0. | ClinicalTrials.gov |
| Secondary | Repeat Hepatectomy Rate | From Day 43 after the first dose through completion or cancellation of the planned repeat hepatectomy | Percentage of enrolled participants who undergo repeat hepatectomy after neoadjuvant treatment. | ClinicalTrials.gov |
| Secondary | R0 Resection Rate | Day 43 through Day 90 after the first dose | Percentage of participants undergoing repeat hepatectomy who achieve microscopically margin-negative resection. | ClinicalTrials.gov |
| Secondary | Surgery Delay Rate | Day 90 after the first dose | Percentage of participants whose planned repeat hepatectomy is delayed beyond Day 90 after the first dose. | ClinicalTrials.gov |
| Secondary | Surgery Cancellation Rate | From completion of neoadjuvant treatment through Day 90 after the first dose | Percentage of participants whose planned repeat hepatectomy is canceled after neoadjuvant treatment. | ClinicalTrials.gov |
| Secondary | Incidence of Surgery-Related Adverse Events and Serious Adverse Events | From repeat hepatectomy through 30 days (±7 days) after surgery | Percentage of participants who experience surgery-related adverse events, serious adverse events, or postoperative complications following repeat hepatectomy. | 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)