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New treatment option for Advanced Malignant Solid Tumor
Official title Plasmodium Immunotherapy for Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT04165590
What this study is testing
- What it's testing
- The purpose of this study is: 1) to evaluate the effectiveness and extended safety of the Plasmodium immunotherapy for the advanced malignant solid tumors. 2) To explore the safe and effective course of the Plasmodium immunotherapy for the advanced malignant solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Aged 18-70 years male or female.
- Patients with advanced maligant solid tumors in lung, liver, prostate, ovary, brain, thyroid and colorectum, etc.
- Patients with primary central nervous system (CNS) tumor or brain metastases from solid tumors, comply with the following standards can participate...
- The patients have measurable tumors based on the criterion of RECIST1.1.
- Tumor classification should be determined by histopathology and pathological report should be provided. If tumor tissue is available, before...
You likely can't join if
- Nasopharyngeal cancer, head and neck tumors.
- HPV positive patients with advanced malignant solid tumors in cervical, anal, vulvar, vaginal and penile.
- Pancreatic cancer patients.
- Small cell lung cancer patients.
- Patients with severe hemoglobin disease or severe G6PD deficiency.
- Patients with splenectomy or splenomegaly.
See the full eligibility criteria
Who can join
- Aged 18-70 years male or female.
- Patients with advanced maligant solid tumors in lung, liver, prostate, ovary, brain, thyroid and colorectum, etc.
- Patients with primary central nervous system (CNS) tumor or brain metastases from solid tumors, comply with the following standards can participate in this study: Up to the clinical trial screening period, the...
- The patients have measurable tumors based on the criterion of RECIST1.1.
- Tumor classification should be determined by histopathology and pathological report should be provided. If tumor tissue is available, before participating in the trail, the research center need to obtain the paraffin...
- For the patients who previously received one or more of the following therapies, the interval time of the termination of chemotherapy (including treatment chemotherapy) or radiotherapy is at least 28 days for patients...
- ECGO score is 0 to 2, and euphagia.
- Expected survival ≥ 3 months.
- WBC≥3× 10\^9/L, PLT ≥ 100× 10\^9/L, HGB ≥ 100 g/L, and albumin ≥ 30 g/L, no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.).
- Patients with gastrointestinal bleeding, hemoptysis or other chronic bleeding symptoms were cured before enrollment.
- Patients with no severe dysfunction of cardiopulmonary, liver and kidney function (child-push grading of liver function A or B, Cr≤ 1.5 x ULN).
- Patient will be able to understand and sign informed consent.
- According to the researcher's judgment, the patient's compliance could meet the needs of follow-up.
What rules you out
- Nasopharyngeal cancer, head and neck tumors.
- HPV positive patients with advanced malignant solid tumors in cervical, anal, vulvar, vaginal and penile.
- Pancreatic cancer patients.
- Small cell lung cancer patients.
- Patients with severe hemoglobin disease or severe G6PD deficiency.
- Patients with splenectomy or splenomegaly.
- Patients with drug addiction or alcohol dependence.
- Have not yet been washed out from the previous therapeutic effects, except the following: the bisphosphonates used for bone metastasis or osteoporosis.
- Uncontrolled pleural effusion, pericardial effusion or ascites.
- Tumor-related pain that are uncontrollable.
- Active malignant tumor metastasis of CNS (progression or controlling the symptoms with anticonvulsants or corticosteroids ).
- Patients with significant immunodeficiency detection ( CD4+T cell absolute count \<200 /ul)
- 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...
- According to the principal investigator's judgment, any other diseases, metabolic disorders, abnormal results of clinical laboratory tests or physical examination, the diseases that leading to usage of the prohibited...
- Have undergone major surgery within 4 weeks of the screening period, or plan to undergo major surgery during the study period, PICC catheter and central venous catheter implantation are excluded.
- Received any antineoplastic drugs, immune cells, antibodies, or vaccines within five drug half-life (not sure the half-life, will be subject to two weeks) during the screening period.
- Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation.
- Receiving any other anti-tumor treatment at the same time.
- Lung function is seriously damaged, the MNW \<39% or can't get out of bed, still feel short of breath when resting.
- Rough cough, dyspnea, without normal diet or difficult to cooperate.
- Poor body condition, the researchers assess that the patients can't tolerate the Plasmodium immunotherapy.
- Pregnant or lactating women.
- Patients that are unable to comply with the research and follow-up procedure.
- Any case that the researchers believe that the patient does not suit for this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kunming, Yunnan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.