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A prospective randomized controlled trial of neoadjuvant therapy with TACE, lenvatinib and camrelizumab versus surgical resection alone for resectable HCC patients with type I / II PVTT

A prospective randomized controlled trial of neoadjuvant therapy with TACE, lenvatinib and camrelizumab versus surgical resection alone for resectable HCC patients with type I / II PVTT

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069972
Enrollment
Unknown
Registered
2023-03-30
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

hepatocellular carcinoma

Interventions

Neoadjuvant treatment group:TACE + lenvatinib + camrelizumab

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) the age is >= 18 and = 10mm and no local treatment such as TACE, radiotherapy, radiofrequency, cryotherapy, etc.). 5) ECOG score: 0-1; Liver function Child-PughA level. 6) Blood routine test: absolute neutrophil count >= 1.5 × 10^9/LHb >=8.5g/L, PLT >=75 × 10^9/L. 7) No history of severe heart rate abnormalities, heart failure, etc; No history of severe respiratory dysfunction or severe pulmonary infection; There was no acute or chronic renal failure, and the creatinine clearance rate was>40mL/min. 8) The expected survival time is greater than 3 months.

Exclusion criteria

Exclusion criteria: 1) diffuse HCC caused by extensive intrahepatic metastasis, portal vein tumor thrombus located in the trunk or opposite portal vein branch of the tumor, and extrahepatic metastasis. 2) other anti-tumor treatments have been used, such as targeted drugs, PD-1, other immunotherapy, surgery, TACE, FOLFOX systemic chemotherapy, and Huaier granule therapy. 3) allergic history of components or excipients of lenvatinib and camrelizumab monoclonal antibodies. 4) patients with any active autoimmune or autoimmune diseases with expected recurrence. 5) patients are being treated with immunosuppressants or systemic hormones to achieve immunosuppression. 6) the patients with proteinuria >= 1 + will receive a 24-hour urinary protein test and those with 24-hour proteinuria >= 1g. 7) patients with other malignant tumors. 8) patients with mental illness. 9) pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
overall survival rate;recurrence-free rate;

Secondary

MeasureTime frame
R0 resection rate;objective response rate;operation delay rate;major pathological response;safety;

Countries

China

Contacts

Public ContactYan Maolin

Fujian Provincial Hospital

yanmaolin74@163.com+86 159 6006 6307

Outcome results

None listed

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