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Evaluation of the efficacy and adverse reactions of DEB-TACE combined with hyperbaric oxygen assisted therapy in patients with primary liver cancer after surgery

Evaluation of the efficacy and adverse reactions of DEB-TACE combined with hyperbaric oxygen assisted therapy in patients with primary liver cancer after surgery

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109493
Enrollment
Unknown
Registered
2025-09-19
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary liver cancer

Interventions

A:DEB-TACE postoperative assisted hyperbaric oxygen therapy
B:Routine follow-up observation after DEB-TACE surgery

Sponsors

Air Force Medical University Xijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with primary hepatocellular carcinoma (HCC) clearly diagnosed by clinical, imaging examination and histopathology, with stage CNLC-IIb-IIIa and BCLC stage B-C; 2. Age between 18~80 years old, gender is not limited; 3. Those who do not have surgical resection or refuse surgical treatment, or who have recurred after surgery, and are suitable for DEB-TACE treatment after multidisciplinary discussion (no extrahepatic metastasis or portal vein main cancer thrombus (branch cancer thrombus is allowed)); 4. Preoperative liver function Child-Pugh grade A-B, normal coagulation function or mild to moderate abnormalities allowed interventional treatment; ECOG performance status score =6 months; 5. The patient has a clear consciousness and can better cooperate with treatment and follow-up; 6. Patients sign the informed consent form and voluntarily participate in this study.

Exclusion criteria

Exclusion criteria: 1. Combined with serious systemic diseases, such as severe cardiopulmonary abnormalities, moderate or above renal insufficiency, severe infection, and a history of obvious gastrointestinal bleeding; 2. Recent treatment of other forms of anti-tumor therapy (such as radiofrequency ablation, microwave ablation, chemotherapy, etc.), and the potential interference and confounding factors of these therapies cannot be ruled out; 3. Femoral or radial artery access puncture has obvious contraindications or previous puncture technique failure, which is not conducive to DEB-TACE (complete portal vein main occlusion); 4. Those with contraindications to hyperbaric oxygen therapy (such as severe alveolar bullae, uncontrolled hypertension (systolic blood pressure (SBP)>=160 mmHg or diastolic blood pressure (DBP)>=100 mmHg), otitis media, intracranial hypertension, pneumothorax, history of seizures, claustrophobia (severe psychological disorder), history of other respiratory infections, etc.); 5. Severe bleeding tendency or abnormal coagulation function, allergic constitution or allergy to treatment-related drugs and iodine contrast agents; 6. Pregnant or lactating women, patients with mental illness, and those who have not signed the informed consent form before enrollment;

Design outcomes

Primary

MeasureTime frame
objective response rate;Disease Control Rate (DCR, covering CR+PR+SD);Incidence of adverse reactions and changes in liver and kidney function (AE; QoL);Quality of life (Karnofsky functional status score) status;

Secondary

MeasureTime frame
Disease progression free survival (PFS);Overall survival rate OS;

Countries

China

Contacts

Public ContactXu Jian

Air Force Medical University Xijing Hospital

xujian@fmmu.edu.cn+86 137 0024 4327

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026