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Clinical study of lipiodol-peptide emulsion TACE therapy combined with intratumoral immunotherapy in improving the therapeutic effect of unresectable hepatocellular carcinoma

Clinical study of lipiodol-peptide emulsion TACE therapy combined with intratumoral immunotherapy in improving the therapeutic effect of unresectable hepatocellular carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082788
Enrollment
Unknown
Registered
2024-04-08
Start date
2024-04-08
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

liver cancer

Interventions

research group:Ultra-stable Lipiodol-Peptuxen-Immune Preparation-Emulsion

Sponsors

Bishan District People's Hospital, Bishan District, Chongqing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient is in good general condition, has no history of other diseases except liver cancer, is not limited to gender, is 18-70 years old, and has a life expectancy of =3 months; 2. Primary cancer confirmed by histology or cytology, or in compliance with the clinical diagnostic criteria (basis of chronic liver disease, typical imaging features, AFP changes) of the "Standards for Diagnosis and Treatment of Primary Liver Cancer" (2022 Edition) promulgated by the National Health Commission patients with hepatocellular carcinoma; 3. BCLC stage B or C, unable to undergo surgical resection 4. There is at least one measurable lesion in the liver; 5. At least one first-level branch of the portal vein is unobstructed; 6. Those whose liver function is Child-A or whose liver function is Child-B can reach Child-A after treatment such as liver protection and nutritional rehydration; 7. Eastern Cooperative Oncology Group status score (ECOG PS) =2; 8. Blood routine, biochemistry, coagulation and other blood indicators are normal; 9. No history of cardiopulmonary disease, normal heart and kidney function, and no cardiotoxic, nephrotoxic or other toxic drugs; 10. Inform the patient in detail about the possible advantages and disadvantages before and after the operation. The patient and his family members voluntarily choose the treatment plan and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have previously received treatment for liver cancer or portal vein tumor thrombus (including surgery, external radiotherapy, molecular targeted drugs, immunotherapy, local ablation, TAI/TACE, etc.) 2. The tumor thrombus extends into the superior mesenteric vein and/or splenic vein; 3. Combined with hepatic vein, segmental inferior vena cava tumor thrombus or extrahepatic metastasis; 4. Combined with diagnosed malignant tumors in other locations; 5. Patients with heart, lung, kidney, brain and other important organ diseases; 6. Contraindications for combined TACE: diffuse liver cancer or tumor volume accounting for 70% or more of the whole liver, refractory large amounts of ascites, high-flow intrahepatic arteriovenous shunt; total bilirubin > 51umol/L and/or albumin < 28g/L, those who fail to improve after symptomatic treatment; combined with active infection, especially inflammation of the bile duct system; female patients who are pregnant or lactating 7. Patients and/or family members do not agree to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
objective response,OR;disease control,DC;PFS,progression-free survival;downsale rate;surgical resection rate;

Secondary

MeasureTime frame
liver function;Blood routine;

Countries

China

Contacts

Public ContactTao Rui

Department of Hepatobiliary Surgery, Bishan District People's Hospital, Bishan District, Chongqing

32620220156289@stu.xmu.edu.cn+86 191 1186 6421

Outcome results

None listed

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