Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Oct 29, 2022
  • participants needed
    30
  • sponsor
    RenJi Hospital
Updated on 29 January 2021

Summary

This is a prospective clinical study aiming to tests the safety and efficacy of lenvatinib in combination with gefitinib in people with lenvatinib resistant hepatocellular carcinoma. This study will help find out if lenvatinib and gefitinib is a safe and useful combination for treating patients with lenvatinib resistant hepatocellular carcinoma.

Details
Condition Targeted Molecular Therapy, Adenocarcinoma, Malignant Adenoma, Adenocarcinoma, Chemotherapy, Chemotherapy, HEPATIC NEOPLASM, Liver Cancer, HEPATOCELLULAR CARCINOMA, Liver Cancer, Malignant Adenoma, liver cell carcinoma
Treatment Lenvatinib and Gefitinib
Clinical Study IdentifierNCT04642547
SponsorRenJi Hospital
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

(1) Unlimited gender, aged 18-75 years; (2) Meets American Association for the
Study of Liver Diseases (AASLD) or European Association for the Study of the
Liver (EASL) clinical diagnostic criteria of hepatocellular carcinoma; (3)
Barcelona Clinic Liver Cancer (BCLC) Stage B or C, and there is at least one
measurable tumor in the liver (long diameter 1cm);(4) progressing after
standard treatment; (5) Unresponsive or resistant to Lenvatinib; (6) Child-
Pugh A or scored 7 B; (7) Eastern Cooperative Oncology Group performance
status score <= 1; (8) Platelet count >= 60x10^9/L, Prothrombin time prolonged
<= 6 seconds

Exclusion Criteria

(1) Uncorrectable coagulopathy with obvious bleeding tendency; (2) Patients
need long-term anticoagulant or anti platelet therapy and cannot stop the
drugs; (3) Patients with unstable or active ulcer or gastrointestinal
bleeding; (4) Heart disease requiring treatment or not well controlled high
blood pressure; (5) Patients with interstitial pneumonia; (6) Hepatic
encephalopathy or refractory ascites requiring treatment; (7) There is a clear
active infection; (8) Receiving radiotherapy/chemotherapy/interventional
therapy for tumor within 4 weeks before the start of the study; (9) Severe
insufficiency of important organs, such as severe cardiopulmonary
insufficiency; (10) Other accompanying anti-tumor treatments; (11) The
investigator assessed that the patient was unable or unwilling to comply with
the protocol
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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