NCT03474822

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
2mo left

Started Aug 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Aug 2018Jun 2026

First Submitted

Initial submission to the registry

March 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

August 10, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

4.9 years

First QC Date

March 16, 2018

Last Update Submit

February 17, 2024

Conditions

Advanced Breast CancerAdvanced Liver Cancer

Keywords

Advanced breast canceradvanced liver cancerPlasmodium immunotherapyPlasmodiun vivax

Outcome Measures

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.

    2 years

Secondary Outcomes (8)

  • Progression free survival (PFS)

    2 years

  • Overall survival

    2 years

  • Tumor marker level

    2 years

  • Objective response rate (ORR)

    2 years

  • the Score of Quality of life

    2 years

  • +3 more secondary outcomes

Study Arms (1)

Blood-stage infection of P.vivax

EXPERIMENTAL

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

Interventions

Blood-stage infection of P.vivaxBIOLOGICAL

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.

Blood-stage infection of P.vivax

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plasmodiun vivax

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21931708RESULT

  • 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.

    PMID: 28228842RESULT

  • 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.

    PMID: 28650446RESULT

  • 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.

    PMID: 28445973RESULT

Central Study Contacts

Qin Li, M.D

CONTACT

0086-20-82258805njlf@cas-lamvac.com

Zhang Su Yi, M.D

CONTACT

0086-20-82258805zhang_suyi@cas-lamvac.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 23, 2018

Study Start

August 10, 2018

Primary Completion

June 30, 2023

Study Completion (Estimated)

June 30, 2026

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

CN(1)