---
title: A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.
nct_id: NCT06844357
overall_status: RECRUITING
phase: PHASE2, PHASE3
sponsor: Zhejiang Raygene Pharmaceuticals Co., Ltd
study_type: INTERVENTIONAL
primary_condition: HCC
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06844357.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06844357"
ct_last_update_post_date: 2025-04-06
last_seen_at: "2026-05-12T07:14:52.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.

**Official Title:** A Multi-center, Randomized, Controlled, Open-label Phase II/III Clinical Trial to Investigate Whether Transarterial Tirapazamine Injection Followed by Transarterial Embolization (TATE) is Superior to Traditional Transarterial Chemoembolization (TACE) in Patients With Intermediate-Stage Hepatocellular Carcinoma (HCC)

**NCT ID:** [NCT06844357](https://clinicaltrials.gov/study/NCT06844357)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 300
- **Lead Sponsor:** Zhejiang Raygene Pharmaceuticals Co., Ltd
- **Conditions:** HCC
- **Start Date:** 2025-03-27
- **Completion Date:** 2029-04-01
- **CT.gov Last Update:** 2025-04-06

## Brief Summary

This phase I/II clinical trial aims to determine the efficacy and safety of TATE compared to TACE in patients with intermediate-stage HCC. The results will provide valuable insights into the potential benefits of TATE as a novel treatment option for HCC.

## Eligibility

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

```
Inclusion Criteria:

* Patients diagnosed with primary hepatocellular carcinoma according to AASLD criteria.
* No evidence of extrahepatic metastasis, regional lymph node involvement, or vascular tumor thrombus.
* Patients must be eligible for TAE or TACE treatment.
* ECOG ≤ 1.
* Child-Pugh score ≤ 7.
* Adequate bone marrow, liver, and kidney function is required.

Exclusion Criteria:

* History of liver transplantation.
* Previous radioemblization or radiotherapy for liver tumors.
* severe cardiovascular or renal diseases, active systemic infections.
* Clinically significant hypoxia (oxygen saturation \< 92% without oxygen supplementation)
```

## Arms

- **TATE** (EXPERIMENTAL) — Patients will receive a fixed dose of 35 mg tirapazamine via hepatic arterial injection, followed by embolization with iodized oil, gelatin sponge and contrast agent suspension.
- **TACE** (EXPERIMENTAL) — Patients will receive cTACE with a mixture of iodized oil （10mL）and epirubicin (50 mg ), followed by embolization with gelatin sponge and contrast agent suspension.

## Interventions

- **tirapazamine** (DRUG) — Intra-arterial injection into the tumor feeding artery
- **Transarterial Embolization (TAE)** (PROCEDURE) — Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
- **TACE** (PROCEDURE) — TACE with epirubicin

## Primary Outcomes

- **Progression-free survival (PFS)** _(time frame: 36 months)_ — Progression-free survival (PFS) assessed by the Independent Radiology Committee (IRC) using mRECIST criteria.

## Secondary Outcomes

- **Complete Response (CR) rate** _(time frame: 36 months)_
- **objective response rate (ORR)** _(time frame: 36 months)_
- **duration of complete response (DOCR)** _(time frame: 36 months)_
- **overall survival (OS)** _(time frame: 36 months)_

## Locations (2)

- Zhongda Hospital, Affiliated to Southeast University, Nanjing, Jiangsu, China — _RECRUITING_
- Lishui Central Hospital, Lishui, Zhejiang, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — 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.zhongda hospital, affiliated to southeast university|nanjing|jiangsu|china` — added _(2026-05-12)_
- `locations.lishui central hospital|lishui|zhejiang|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06844357.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06844357*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*