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

Phase 4
18 Years
70 Years
Open (Enrolling)
Multiple Drug Use

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Trial Information

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

Primary liver cancer (hereinafter abbreviated as PLC) is one of the most common types of
malignant tumors in clinical practices. Its global prevalence is rising year-on-year and
surpasses 626,000 per year. Ranking at No. 5 among all malignant tumors, its mortality rate
approaches 600,000 per year and becomes No.3 of tumor-related death. As one of the prevalent
regions of PLC in the world, China has a morbidity population of around 55%. Among the
tumor-related death, it stands at No. 2 second only to lung cancer. So PLC has been a major
hazard to health and life for Chinese citizens. Surgical resection has remained the first
therapeutic choice of PLC. However, the disease course of PLC is insidious. In clinical
practices, less than 30% of PLC patients may be treated surgically by hepatectomy. And their
postoperative occurrences of recurrence and metastasis stay at a high level. As demonstrated
by large-sample clinical trials in China, the 5-year postoperative recurrent rate of PLC was
as high as 61.5%. The relevant studies have indicated that the surgical therapy of PLC has
encountered a bottle-neck over the last decade and the control rates of postoperative
recurrence or metastasis remain basically the same. Therefore the recurrence and metastasis
of PLC are important limiting factors for its clinical therapeutic gains. Effectively
lowering the post-therapeutic recurrence and metastasis of PLC has become a breakthrough
point for improved clinical efficacies. At present, there is still no standard therapeutic
protocol for the prevention of recurrence and metastasis of PLC.

Independently developed recently by China, licartin has been the first radioimmunological
targeted therapeutic agent approved for PLC in the world. Since its marketing in 2007, it
has achieved excellent clinical efficacies and social recognition. As demonstrated by the
results of relevant basic and clinical researches, licartin had definite efficacies for
primary hepatocellular carcinoma and it could boost the efficacies of integrated PLC
therapy, prolong the patient survivals and enhance the benefits of clinical therapeutics.
Early studies have also proved that it could prolong the survivals of PLC, improve the
quality of life and prevent the postoperative recurrence and metastasis. The present
clinical trial is intended to examine the efficacy and safety of radioimmunotherapy via
intravenous infusion of licartin plus sequential immunotherapy of CIK cell in the controls
of disease progression, effective prolonging of recurrent time and prevention of recurrence
or metastasis of primary hepatocellular carcinoma.

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.

Inclusion Criteria:

- Definite pathological diagnosis of hepatocellular carcinoma

- Excellent healing of surgical wounds, no overt surgical complication and stable

- Such imaging examinations as ultrasound, CT and MRI reveal no definite tumor foci

- Subject's physical status:Karnofsky performance status score ≥70 points

- Metuxitab skin test negative

- Receiving no radiotherapy, chemotherapy or molecular targeted therapy within 4 weeks

- Male/female aged 18-70 years

- Expected survival period > 3 months

- Voluntary group participation, excellent compliance, cooperative in observations and
signing a written informed consent form.

Exclusion Criteria:

- Poor general constitution with obviously impaired liver function (bilirubin > 3 folds
of normal upper limit and serum albumin <30 g/L)

- Blood routine examination: white blood cell <4.0×109/L or platelet count <80×109/L

- Definite tumor foci found on such imaging examinations of ultrasound, CT or MRI

- Postoperative onset of recurrence or metastasis and no clinical remission after

- Severe infection, such as hepatic abscess

- Abnormal thyroid functions

- Obvious cases of pleural effusion and ascites

- Diffuse systemic metastasis and therapy is not expected to prolong the patient's
survival period

- Poor compliance

- Patients with a history of hypersensitivity to biological preparations,
hypersensitive physique or currently in a hypersensitive state

- Pregnant and lactating women

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Yan Zhao, Doctor

Investigator Role:

Study Director

Investigator Affiliation:

Director of Pharmacology Base


China: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

May 2014

Related Keywords:

  • Multiple Drug Use
  • Iodine[131I] Metuximab Injection
  • Carcinoma
  • Carcinoma, Hepatocellular