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Clinical study of rre-combined nimouzumab for reversing drug resistance in hepatocellular carcinoma after failure of treatment of 1-L lenalutinib-containing regimen

Clinical study of rre-combined nimouzumab for reversing drug resistance in hepatocellular carcinoma after failure of treatment of 1-L lenalutinib-containing regimen

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068872
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

hepatocelluar carcinoma

Interventions

single arm,test group:nimotuzumab,400mg,D1,8,15,28d/cycle

Sponsors

The Third Affiliated Hospital of Navy Military Medical University (Shanghai Eastern Hepatobiliary Surgery Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) clinically or pathologically and cytologically diagnosed hepatocellular carcinoma; 2) confirmed radiographic progression after first-line treatment with lenvatinib with or without PD-1 monoclonal antibody; 3) high EGFR expression by immunohistochemistry or EGFR amplification by genetic testing in tumor tissue; 4) measurable lesions according to mRECIST criteria (see Appendix 1); 5) age from 18 to 75 years; 6) WHO/ECOG performance score (see Appendix 2) reached 0-2; 7) relatively adequate bone marrow hematopoietic reserve (neutrophil count > 1.0 x 10 ^ 9/L, platelet count > 50 x 10 ^ 9/L) 8) adequate liver reserve (bilirubin = 3 months 11) signed the informed consent

Exclusion criteria

Exclusion criteria: 1) after more than 2 lines of systemic therapy; 2) there are associated secondary malignant tumors or other tumors within 3 years before the start of the study, there are brain or meningeal metastases; 3) chronic diarrhea or colorectal inflammatory conditions, or affect systemic administration of untreated obstruction or subobstruction; 4) active infection or other serious infections that may hinder the patient from receiving planned treatment. For example, long-term uncontrolled destruction of biliary branch bacterial cholangitis; 5) history of uncontrolled drug abuse or mental disorders; 6) patients with concomitant diseases that may seriously endanger their own safety or may affect the completion of the study according to the investigator 's judgment; 7) participated in other clinical trials; 8) pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
progress free suivival;overall survival;safety;

Countries

China

Contacts

Public ContactYuan Zhengang

The Third Affiliated Hospital of Navy Military Medical University (Shanghai Eastern Hepatobiliary Surgery Hospital)

yuanzg@163.com+86 138 1722 1812

Outcome results

None listed

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