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PD-1 inhibitor and TACE are used as an adjuvant therapy for hepatocellular carcinoma patient co-infected with HIV after hepatectomy, an open lable, single arm study.

PD-1 inhibitor and TACE are used as an adjuvant therapy for hepatocellular carcinoma patient co-infected with HIV after hepatectomy, an open lable, single arm study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043536
Enrollment
Unknown
Registered
2021-02-21
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-14

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

Conditions

hepatocellular carcinoma

Interventions

1:PD-1 inhibitor and TACE

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-75 years; 2.CNCL(2019) stage I-IIIa,HCC is diagnosed by pathologist after hepatectomy; 3.HIV infection; Accepted HAART at least 1 week before operation and continue more than 2 years after operation. 4.Gd-EOB-DTPA enhanced MRI, DSA, chest CT do not find intra-/extra-liver tumor is found 4+/-1 weeks after operation.

Exclusion criteria

Exclusion criteria: 1.Patients with other special infections should not be treated by operation or immunotherapy; 2.Not R0 resection or intra-/extra-liver tumor is found 4+/-1 weeks after operation; 3.PVTT type III-IV; 4.Over screening schedule date; 5.Ever used PD-1/PD-L1 inhibitor or other anti-tumor medicine 4 weeks before or after operation; 6.Child-Pugh score >=8 or with ascites, Cr>UN,eGFR<90,WBC<=3.0E+9/L,PLT<=60E+9/L,abnormal thyroid function,ECOG score 2-4; 7.Combind with immuno-disease, sentive to PD-1 inhibitor,mild/severe pheumonia, myocarditis,heart funtion equal or more than grade 2,pregnancy,active viral hepatitis.

Design outcomes

Primary

MeasureTime frame
Recurrence free survival time within two years after operation;

Contacts

Public ContactYangqing Huang

Shanghai Public Health Clinical Center

eric_huangyq@163.com+86 21-37990333-6338

Outcome results

None listed

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