Plasmodium Immunotherapy for Breast and Liver Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCAS Lamvac Biotech Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Blood-stage infection of P.vivax
Biological/VaccineThe 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Blood-stage infection of P.vivaxExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 yearsSecondary outcomes
1
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).
Time frame
2 years2
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).
Time frame
2 years3
Tumor marker level
The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.
Time frame
2 years4
Objective response rate (ORR)
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov