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Clinical study of TACE combined with immunotherapy in patients with intermediate and advanced hepatocellular carcinoma

Clinical study of TACE combined with immunotherapy in patients with intermediate and advanced hepatocellular carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045525
Enrollment
Unknown
Registered
2021-04-18
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

Hepatocellular carcinoma

Interventions

Control group:Transcatheter arterial chemoembolization (TACE)
Experimental group:TACE+Nivolumab Hepatic Artery Perfusion

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged >=18 and <=75 years; 2.Clinical or pathological diagnosis of HCC; 3.Complete clinical, laboratory and imaging data; 4.The liver tumor load is less than 70% (the tumor occupies the volume of the whole liver), there is no main portal vein tumor thrombus or there is main portal vein tumor thrombus, but the collateral is well established; 5.Liver cancer CNLC stage IIb-IIIb; 6.Child-Pugh grade A or B; 7.ECOG -PS score: 0-2; 8.There are no other contraindications for angiography (e.g., contrast agent allergy, uncontrolled infection, uncorrected coagulation disorders, etc.); 9.No contraindications for the use of PD-1 (e.g. autoimmune diseases, history of organ transplantation, etc.); 10.Subjects voluntarily join the study, sign an informed consent form, and be able to cooperate with follow-up and complete the research project.

Exclusion criteria

Exclusion criteria: 1.Patients with abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds), with bleeding tendency or receiving thrombolysis or anticoagulation therapy; 2.Patients with grade II or above bone marrow suppression; 3.Patients with active infectious disease; 4.Patients with severe heart, lung, kidney, brain and other basic diseases, unable to tolerate intervention therapy; 5.Patients cannot tolerate a complete treatment cycle (>=2 times) and cannot objectively evaluate the therapeutic effect.

Design outcomes

Primary

MeasureTime frame
Objective response rate (ORR);

Secondary

MeasureTime frame
Overall survival (OS);Disease control rate (DCR);

Countries

China

Contacts

Public ContactWang Maoqiang

Chinese PLA General Hospital

wangmq@vip.sina.com+86 10 66937190

Outcome results

None listed

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