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

NCT01758679 | Unknown Phase 4 DMC

• 1 other identifier: CIH-XWG-201205001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Drug Use

Keywords

Iodine[131I] Metuximab Injection

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  1 year

Study Arms (1)

Licartin，Licartin and CIK

EXPERIMENTAL

Intravenous Licartin 27.75 M Bq(0.75 mCi)/kg Licartin and CIK

Biological: Licartin and CIK

Interventions

Licartin and CIK BIOLOGICAL

Licartin and CIK

Licartin，Licartin and CIK

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

metuximab

Study Officials

• Yan Zhao, Doctor

  Director of Pharmacology Base

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2012-08

Locations

CN (1)