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Tirellizumab combined with Lenvastinib for perioperative treatment of resectable hepatocellular carcinoma and benefit prediction by ctDNA

Efficacy and safety of Tirellizumab combined with Lenvastinib for perioperative treatment of resectable hepatocellular carcinoma and benefit prediction by ctDNA: a prospective phase II study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079770
Enrollment
Unknown
Registered
2024-01-11
Start date
2024-01-11
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

hepatocellular carcinoma

Interventions

Perioperative Treatment group:neoadjuvant therapy (tirellizumab combined with lenvatinib, 3 cycles), liver section, postoperative adjuvant therapy (tirellizumab combined with lenvatinib, 6 cycles)

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 years and 75 years; 2. Hepatocellular carcinoma diagnosed by pathological examination; 3. CNLC Stage Ib-IIIa; 4. Surgical assessment is resectable: residual liver volume more than 40% for patients with liver cirrhosis and more than 30% for patients without liver cirrhosis; 5. Child-Pugh =7 points; 6. ECOG PS 0-1; 7. Laboratory test results should meet: (1) absolute neutrophil count =2.0×10^9/L; hemoglobin =85g/L; platelet count =75×10^9/L; (2) serum albumin =30g/L; total bilirubin 2000IU/mL requires antiviral treatment for 2 weeks. 8. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Received any anti-tumor therapy in the past; 2. In combined with severe heart, lung, kidney or other important organ dysfunction, unable to tolerate general anesthesia surgery; 3. With main portal vein cancer thrombus; 4. History of severe allergic reactions to other monoclonal antibodies; 5. Other malignant tumors were combined within 2 years; 6. With immune deficiency or autoimmune disease; 7. HIV infection; 8. Other investigators believe that it may be risky to receive the study treatment or not suitable for inclusion

Design outcomes

Primary

MeasureTime frame
1-year recurrence-free survival;

Secondary

MeasureTime frame
Major pathological response rate;Disease-free survival;Event-free survival;overall survival;Pathological complete response rate;Rate of microvascular invasion;Incidence of adverse events;Incidence of postoperative complications;

Countries

China

Contacts

Public ContactKun Wang

Beijing Cancer Hospital

wang-kun@vip.sina.com+86 10 8819 6098

Outcome results

None listed

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