---
title: M-TACE Treatment for Unresectable Hepatocellular Carcinoma
nct_id: NCT05875558
overall_status: UNKNOWN
phase: NA
sponsor: Shanghai Zhongshan Hospital
study_type: INTERVENTIONAL
primary_condition: Hepatocellular Carcinoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05875558.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05875558"
ct_last_update_post_date: 2023-05-25
last_seen_at: "2026-05-12T06:44:05.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# M-TACE Treatment for Unresectable Hepatocellular Carcinoma

**Official Title:** Lipiodol Combined With Microspheres TACE for Unresectable HCC

**NCT ID:** [NCT05875558](https://clinicaltrials.gov/study/NCT05875558)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Shanghai Zhongshan Hospital
- **Conditions:** Hepatocellular Carcinoma
- **Start Date:** 2022-07-01
- **Completion Date:** 2024-07-01
- **CT.gov Last Update:** 2023-05-25

## Brief Summary

This study aims to investigate the safety and efficacy of transarterial chenmoembolization（TACE） combined with microspheres for unresectable hepatocellular carcinoma(HCC).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. 18≤Age\<80 on day of signing informed consent.
2. Have histologically confirmed diagnosis or radiological diagnosis of HCC with at least one \>3cm targeted lesion.
3. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease, BCLC stage A disease but refuse a surgical or ablation therapy.
4. Have a Child-Pugh Class A/B（\<7） liver score.
5. Have a performance status of 0 or 1 using the ECOG.
6. Have a predicted life expectancy of greater than 3 months.

Exclusion Criteria:

1. The targeted lesions have received TACE or other locoregional therapy within 3 months.
2. Tumor burden over 70% of the liver volume.
3. Lesions can not be measured by mRECIST.
4. Has a diagnosed additional malignancy.
5. Patients with Hb\<9.0g/dL, WBC\<1.0×10\^9/L， TB\>3mg/dL，ALT/AST\>5 UL, ALB\<2.8g/dL， INR\>2.3, Cr \>2mg/mL or CCr\<30mL/min.
6. Severe heart, lung or cerebral disease.
```

## Arms

- **M-TACE** (EXPERIMENTAL)

## Interventions

- **M-TACE** (PROCEDURE) — Lipiodol combined with microspheres

## Primary Outcomes

- **ORR** _(time frame: 1 month after first mTACE)_ — Objective response rate according to the mRECIST
- **ORR** _(time frame: 3 months after first mTACE)_ — Objective response rate according to the mRECIST

## Secondary Outcomes

- **OS** _(time frame: 1 year)_
- **OS** _(time frame: 3 years)_

## Locations (1)

- Department of Interventional Radiology, Zhongshan Hospital, Fudan University., Shanghai, Shanghai Municipality, China

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of interventional radiology, zhongshan hospital, fudan university.|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05875558.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05875558*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*