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A single-center, prospective, randomized clinical trial of EGFR inhibitor plus lenvatinib versus regorafenib in lenvatinib-resistant EGFR-positive advanced HCC patients

A single-center, prospective, randomized clinical trial of EGFR inhibitor plus lenvatinib versus regorafenib in lenvatinib-resistant EGFR-positive advanced HCC patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062854
Enrollment
Unknown
Registered
2022-08-21
Start date
2022-08-25
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

hepatocellular carcinoma

Interventions

Experimental group:Lenvatinib plus gefitinib

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. No history of allergy to lenvatinib, regorafenib, gefitinib or its components; 2. Aged > 18 years, and 35 g/L; 11. Blood routine: WBC > 2500, PLT > 600,000; 12. Coagulation function: PT prolongation < 2 s; 13. ECOG score < 2 points; 14. The pathological result is hepatocellular carcinoma (HCC); 15. Understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Patients who have previously used anti-tumor therapy other than lenvatinib; 3. Patients who received lenvatinib treatment and then received radiotherapy or radiofrequency ablation; 4. Patients who received more than one TACE treatment after receiving lenvatinib treatment; 5. Patients combined with other malignant tumors; 6. Patients with mental illness; 7. Patients who have participated in other clinical trials in the past three months.

Design outcomes

Primary

MeasureTime frame
Tumor size;Alpha fetal protein;Protein Induced by Vitamin K Absence or Antagonist-II;overall survival;

Secondary

MeasureTime frame
progression free survival;objective response rate;Adverse Event;Safety;

Countries

China

Contacts

Public ContactLunxiu Qin

Huashan Hospital Affiliated to Fudan University

qinlx99@vip.163.com+86 13761801800

Outcome results

None listed

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