Multiple Drug UsePhase 4NCT01758679
A Clinical Trail of Iodine[131I] Metuximab Injection With CIK Cells for Preventing Hepatocellular Carcinoma
A Phase 4 study testing Licartin and CIK in people with Multiple Drug Use, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Drug Use
- What is being tested?
- Licartin and CIK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Yan Zhao, Doctor, 022-23340123 ext. 6012, yanzhaotj@126.com
About this study
Official title: A Clinical Trail of Iodine[131I] Metuximab Injection With CIK Cells for Preventing Relapse and Metastasis of 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.
Read the detailed 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.
- Conditions
- Multiple Drug Use
- Being tested
- Licartin and CIK
- Keywords
- Iodine[131I] Metuximab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Licartin and CIKBiological
Licartin and CIK
| Study group | Role | What they receive |
|---|---|---|
| Licartin，Licartin and CIK | Experimental | Intravenous Licartin 27.75 M Bq(0.75 mCi)/kg Licartin and CIK Receives: Biological: Licartin and CIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJan 2012
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Drug UseStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Zhao, Doctor, Study director, Director of Pharmacology Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758679
- Sponsor's protocol ID
- CIH-XWG-201205001
- Status last verified
- Aug 2012
- First submitted
- 29 Aug 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trail of Iodine[131I] Metuximab Injection With CIK Cells for Preventing Relapse and Metastasis of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01758679
- Acronym / sponsor ID
- CIH-XWG-201205001
- Conditions
- Multiple Drug Use
- Keywords
- Iodine[131I] Metuximab Injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Licartin，Licartin and CIK | Experimental | Biological: Licartin and CIKIntravenous Licartin 27.75 M Bq(0.75 mCi)/kg Licartin and CIK |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Licartin and CIKLicartin and CIK | Biological | Licartin，Licartin and CIK |
Primary outcome
Progression-free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
Related trials for Multiple Drug Use
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Aztreonam-Avibactam in Immunocompromised Hosts
Enterobacteriaceae Infections, Carbapenem-Resistant Enterobacteriaceae Infection
Recruiting
GORE® ENFORM Biomaterial Product Study
Hernia, Ventral, Hernia, Hiatal
Active, not recruitingPhase 3
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines
Psoriatic Arthritis
Enrolling by invitation
Testing the Impact of Pre-visit Priming for Medications
Deprescribing, Statin Prescribing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
Yan Zhao, Doctor study director
Director of Pharmacology Base
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Licartin and CIK in people with Multiple Drug Use, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.