Plasmodium Immunotherapy for Breast and Liver Cancers
Primary Purpose
Advanced Breast Cancer, Advanced Liver Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Blood-stage infection of P.vivax
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer focused on measuring Advanced breast cancer, advanced liver cancer, Plasmodium immunotherapy, Plasmodiun vivax
Eligibility 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.
Sites / Locations
- Plasmodiun vivaxRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood-stage infection of P.vivax
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0
Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.
Secondary Outcome Measures
Progression free survival (PFS)
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).
Overall survival
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).
Tumor marker level
The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.
Objective response rate (ORR)
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Quality of life
Patients are regularly filled with QLQ-C30 (cancer patient quality of life scale) to assess the quality of life of the patients.
1 year of survival rate
The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated * 100%.
2 year of survival rate
The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated * 100%.
Immunological index
Detection of absolute number of immune cells(such as CD3+CD4+、CD3+CD8+ and so on)in peripheral blood by flow cytometry.
Full Information
NCT ID
NCT03474822
First Posted
March 16, 2018
Last Updated
May 8, 2019
Sponsor
CAS Lamvac Biotech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03474822
Brief Title
Plasmodium Immunotherapy for Breast and Liver Cancers
Official Title
Clinical Study of Plasmodium Immunotherapy for Advanced Breast Cancers and Advanced Liver Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CAS Lamvac Biotech Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer, Advanced Liver Cancer
Keywords
Advanced breast cancer, advanced liver cancer, Plasmodium immunotherapy, Plasmodiun vivax
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood-stage infection of P.vivax
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Blood-stage infection of P.vivax
Intervention Description
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 Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0
Description
Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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).
Time Frame
2 years
Title
Overall survival
Description
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).
Time Frame
2 years
Title
Tumor marker level
Description
The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.
Time Frame
2 years
Title
Objective response rate (ORR)
Description
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Time Frame
2 years
Title
Quality of life
Description
Patients are regularly filled with QLQ-C30 (cancer patient quality of life scale) to assess the quality of life of the patients.
Time Frame
2 years
Title
1 year of survival rate
Description
The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated * 100%.
Time Frame
2 years
Title
2 year of survival rate
Description
The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated * 100%.
Time Frame
2 years
Title
Immunological index
Description
Detection of absolute number of immune cells(such as CD3+CD4+、CD3+CD8+ and so on)in peripheral blood by flow cytometry.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qin Li, M.D
Phone
0086-20-82258805
Email
njlf@cas-lamvac.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Su Yi, M.D
Phone
0086-20-82258805
Email
zhang_suyi@cas-lamvac.com
Facility Information:
Facility Name
Plasmodiun vivax
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Su Yi, M.D
Phone
0086-20-82258805
Email
zhang_suyi@cas-lamvac.com
First Name & Middle Initial & Last Name & Degree
Hou Jiang Hou, M.D
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21931708
Citation
Chen L, He Z, Qin L, Li Q, Shi X, Zhao S, Chen L, Zhong N, Chen X. Antitumor effect of malaria parasite infection in a murine Lewis lung cancer model through induction of innate and adaptive immunity. PLoS One. 2011;6(9):e24407. doi: 10.1371/journal.pone.0024407. Epub 2011 Sep 9.
Results Reference
result
PubMed Identifier
28228842
Citation
Qin L, Chen C, Chen L, Xue R, Ou-Yang M, Zhou C, Zhao S, He Z, Xia Y, He J, Liu P, Zhong N, Chen X. Worldwide malaria incidence and cancer mortality are inversely associated. Infect Agent Cancer. 2017 Feb 14;12:14. doi: 10.1186/s13027-017-0117-x. eCollection 2017.
Results Reference
result
PubMed Identifier
28650446
Citation
Yang Y, Liu Q, Lu J, Adah D, Yu S, Zhao S, Yao Y, Qin L, Qin L, Chen X. Exosomes from Plasmodium-infected hosts inhibit tumor angiogenesis in a murine Lewis lung cancer model. Oncogenesis. 2017 Jun 26;6(6):e351. doi: 10.1038/oncsis.2017.52.
Results Reference
result
PubMed Identifier
28445973
Citation
Liu Q, Yang Y, Tan X, Tao Z, Adah D, Yu S, Lu J, Zhao S, Qin L, Qin L, Chen X. Plasmodium parasite as an effective hepatocellular carcinoma antigen glypican-3 delivery vector. Oncotarget. 2017 Apr 11;8(15):24785-24796. doi: 10.18632/oncotarget.15806.
Results Reference
result
Learn more about this trial
Plasmodium Immunotherapy for Breast and Liver Cancers
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