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

Multiple Drug Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01758679
• Other study ID #: CIH-XWG-201205001
• Status: Recruiting
• Phase: Phase 4
• First received: August 29, 2012
• Last updated: February 14, 2016
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: August 2012
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Definite pathological diagnosis of hepatocellular carcinoma

• Excellent healing of surgical wounds, no overt surgical complication and stable disease

• 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 pre-therapy

• 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 therapy

• 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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Multiple Drug Use

Intervention

Biological:
• Licartin and CIK
Licartin and CIK

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		1 year	Yes