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Efficacy and safety of lenvatinib combined with tirellizumab as perioperative adjuvant (preoperative neoadjuvant + postoperative adjuvant) treatment in resectable liver cancer: a prospective, open-label, single-arm, Phase II clinical study

Efficacy and safety of lenvatinib combined with tirellizumab as perioperative adjuvant (preoperative neoadjuvant + postoperative adjuvant) treatment in resectable liver cancer: a prospective, open-label, single-arm, Phase II clinical study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084971
Enrollment
Unknown
Registered
2024-05-29
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

Liver cancer

Interventions

Intervention group:Perioperative adjuvant (preoperative neoadjuvant + postoperative adjuvant) therapy

Sponsors

The Eighth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of hepatocellular carcinoma or pathologically confirmed hepatocellular carcinoma by puncture biopsy (Clinical diagnosis of hepatocellular carcinoma is made according to the Guidelines for Primary Liver Cancer Diagnosis and Treatment 2022) 2. Have not received systematic therapy related to hepatocellular carcinoma before; 3. At least one measurable lesion meets RECIST v1.1 criteria 4. HCC with CNLC stage IIb or IIIa; 5. Potential resectable liver cancer in liver cancer stages Ia, Ib, IIa and IIb and IIIa in China; 6. Eastern Cooperative Oncology Group performance status (ECOG PS) score 0-1

Exclusion criteria

Exclusion criteria: 1. The patient has been diagnosed with intrahepatic cholangiocarcinoma, mixed liver cancer, or other liver malignancies 2. Have had malignant tumors other than HCC within the past 5 years; 3. The postoperative pathological diagnosis was non-R0 resection or did not meet the criteria for radical postoperative diagnosis of liver cancer (the criteria for radical postoperative diagnosis of liver cancer are determined according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer 2022). 4. Is or has received an organ transplant or allogeneic bone marrow transplant; 5. Liver function Child-pugh B or C grade

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival;

Secondary

MeasureTime frame
Major pathological response ;Overall survival;Objective Response Rate;Pathological complete response;Immune-related adverse events;

Countries

China

Contacts

Public ContactZheng Zhou

The Eighth Affiliated Hospital, Sun Yat-sen University

zhouzh76@mail.sysu.edu.cn+86 138 2843 4680

Outcome results

None listed

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