NCT06844357 A Phase II/III Trial Comparing Transarterial Tirapazamine Embolization (TATE) With cTACE for Intermediate-stage Liver Cancer.
| NCT ID | NCT06844357 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Zhejiang Raygene Pharmaceuticals Co., Ltd |
| Condition | HCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 300 participants in total. It began in 2025-03-27 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Criteria
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)
Contact & Investigator
Gaojun Teng, M.D
PRINCIPAL INVESTIGATOR
Zhongda Hospital
Frequently Asked Questions
Who can join the NCT06844357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06844357 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06844357 currently recruiting?
Yes, NCT06844357 is actively recruiting participants. Contact the research team at bill.shen@raygene.cn for enrollment information.
Where is the NCT06844357 trial being conducted?
This trial is being conducted at Nanjing, China, Lishui, China.
Who is sponsoring the NCT06844357 clinical trial?
NCT06844357 is sponsored by Zhejiang Raygene Pharmaceuticals Co., Ltd. The principal investigator is Gaojun Teng, M.D at Zhongda Hospital. The trial plans to enroll 300 participants.