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Plasmodium Immunotherapy for Breast and Liver Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474822
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
CAS Lamvac Biotech Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate the safety and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced breast cancers and advanced liver cancers.The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Advanced Liver Cancer Biological: Blood-stage infection of P.vivax Phase 1 Phase 2

Detailed Description:
This study is to enroll 30 patients in each type of cancer. Each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10^7 Plasmodium parasites and be observed for the exact infection time, parasitemia condition and infection course; principal clinical symptoms such as fever; gastrointestinal reaction; peripheral blood parameters; the changes in heart, lung, liver and kidney function. Preliminarily observe the changes in the primary and metastatic lesions of the cancer, the tolerance of patients to Plasmodium infection, changes in tumor-related parameters and immunological related parameters.The rate of the erythrocytes infected by plasmodium is controlled below 0.01% by using Artemisinin during the course, and clinical treatment is conduced according to the microscopic examination to ensure that no serious complications occurs.The duration of the planned treatment of each subject is 4-6 weeks. The time of the treatment course is based on vaccination with P.vivax-infected red blood cells. After 4-6 weeks, parasitemia will be terminated by antimalarial drugs for terminating the treatment of Plasmodium immunotherapy (the immunological treatment effect may persist after the termination of Plasmodium infection), and then the patients are followed up for 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Plasmodium Immunotherapy for Advanced Breast Cancers and Advanced Liver Cancers
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Blood-stage infection of P.vivax
This is a single arm study that plans to enroll 30 patients in each type cancer and each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10^7 Plasmodium parasites. The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.
Biological: Blood-stage infection of P.vivax
The P. vivax infected blood will be confirmed to follow the national standard of blood donation to ensure that only P. vivax is included, excluding the presence of P. falciparum. Exclude other infectious diseases according to the test of national standard of blood donation.




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0 [ Time Frame: 2 years ]
    Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 2 years ]
    Progression free survival (PFS): Starting from treatment until the disease progression is first found or the time of any cause of death (disease progression refers to tumor growth, or metastasis of primary tumor, or discovery of new lesions).

  2. Overall survival [ Time Frame: 2 years ]
    The time starting from the treatment to death of whatever causes (when subjects have lost for follow-up before death, the last follow-up time will be calculated as the time of death).

  3. Tumor marker level [ Time Frame: 2 years ]
    The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.

  4. Objective response rate (ORR) [ Time Frame: 2 years ]
    The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.

  5. Quality of life [ Time Frame: 2 years ]
    Patients are regularly filled with QLQ-C30 (cancer patient quality of life scale) to assess the quality of life of the patients.

  6. 1 year of survival rate [ Time Frame: 2 years ]
    The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated * 100%.

  7. 2 year of survival rate [ Time Frame: 2 years ]
    The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated * 100%.

  8. Immunological index [ Time Frame: 2 years ]
    Detection of absolute number of immune cells(such as CD3+CD4+、CD3+CD8+ and so on)in peripheral blood by flow cytometry.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-70 years of age, male or female.
  • Patients with advanced breast cancer and advanced liver cancer confirmed by histopathology and imaging; and imaging lesions of the tumor are clear and measurable.
  • Previously received at least one standard therapy.
  • The time interval of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 1 months for patients who had received chemotherapy or radiotherapy; at least 5 half-life for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions).
  • ECGO score of 0 or 1;
  • Expected survival ≥ 6 months;
  • PLT ≥100× 10^9/L, NE ≥ 1.5 × 10^9/L, and HGB ≥ 100 g/L; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.).
  • The peripheral blood count of immune cells is close to normal or normal, the immune function test result is close to or at the level of normal population, and the function of heart, lung, liver and kidney are basically normal (the liver function classification of Child-push is A or B, Cr≤1.5×ULN);
  • Patient compliance meets the need for follow-up;
  • The subjects are able to understand and sign informed consent.

Exclusion Criteria:

  • Patients with severe hemoglobin disease or severe G6PD deficiency;
  • Patients with splenectomy or splenomegaly;
  • Patients with drug addiction or alcohol dependence;
  • With the following diseases or conditions: serious or uncontrolled systemic disease or any unstable systemic diseases (including but not limited to active infection, grade three hypertension, unstable angina, congestive heart failure, class III or IV heart disease, severe arrhythmia, liver and kidney dysfunction or metabolic disease), a clear history of neurological or psychiatric disorders, etc.
  • Accept any other anti-tumor treatment at the same time.
  • Patients with significantly lower immune function than those in the normal population.
  • Lung function is seriously damaged, the MNW <39% or can't get out of bed, still feel short of breath when resting.
  • Advanced liver cancer patients with severe varicose vein in the esophagus.
  • Rough cough, dyspnea, without normal diet or difficult to cooperate.
  • Poor body condition, the researchers assess that the patients can't tolerate the immune therapy.
  • Pregnant or lactating women.
  • Women of childbearing age with positive result for pregnancy tests.
  • Any case that researchers believe that the patient does not suit for this clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474822


Contacts
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Contact: Qin Li, M.D 0086-20-82258805 njlf@cas-lamvac.com
Contact: Zhang Su Yi, M.D 0086-20-82258805 zhang_suyi@cas-lamvac.com

Locations
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China, Guangdong
Plasmodiun vivax Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Zhang Su Yi, M.D    0086-20-82258805    zhang_suyi@cas-lamvac.com   
Principal Investigator: Hou Jiang Hou, M.D         
Sponsors and Collaborators
CAS Lamvac Biotech Co., Ltd.
Publications of Results:
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Responsible Party: CAS Lamvac Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03474822    
Other Study ID Numbers: KGYY-001
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CAS Lamvac Biotech Co., Ltd.:
Advanced breast cancer
advanced liver cancer
Plasmodium immunotherapy
Plasmodiun vivax
Additional relevant MeSH terms:
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Malaria
Breast Neoplasms
Liver Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Protozoan Infections
Parasitic Diseases