Clinical Trial · NCT01758679

A Clinical Trail of Iodine[131I] Metuximab Injection With CIK Cells for Preventing Hepatocellular Carcinoma

Overview

This clinical trial is designed to provide one kind of modalities for preventing the recurrence and metastasis of PLC. If the expected therapeutic efficacy is achieved, it shall contribute actively to boosting the therapeutic level of PLC, prolonging its recurrent time and enhancing its overall survival. And it may also raise the clinical recognition of this technology, promote its clinical applications and generate excellent social reputations and economic returns.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase

Phase 4

Contacts

Yan Zhao, Doctor (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT01758679

Drug / Compound

metuximab

Isotope(s):
Target(s):
  • HAb18G/CD147
Ligand Class: Antibodies

Eligibility

Inclusion

  • Such imaging examinations as ultrasound, CT and MRI reveal no definite tumor foci
  • Receiving no radiotherapy, chemotherapy or molecular targeted therapy within 4 weeks pre-therapy
  • Subject's physical status:Karnofsky performance status score ≥70 points
  • Metuxitab skin test negative
  • Expected survival period \> 3 months
  • Definite pathological diagnosis of hepatocellular carcinoma
  • Excellent healing of surgical wounds, no overt surgical complication and stable disease

Exclusion

  • Pregnant and lactating women
  • Severe infection, such as hepatic abscess
  • Obvious cases of pleural effusion and ascites
  • Abnormal thyroid functions
  • Definite tumor foci found on such imaging examinations of ultrasound, CT or MRI
  • Postoperative onset of recurrence or metastasis and no clinical remission after therapy
  • Patients with a history of hypersensitivity to biological preparations, hypersensitive physique or currently in a hypersensitive state
  • Blood routine examination: white blood cell \<4.0×109/L or platelet count \<80×109/L
  • Poor compliance
  • Poor general constitution with obviously impaired liver function (bilirubin \> 3 folds of normal upper limit and serum albumin \<30 g/L)
  • Diffuse systemic metastasis and therapy is not expected to prolong the patient's survival period