Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT04165590

Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

Led by CAS Lamvac Biotech Co., Ltd. · Updated on 2024-02-20

60

Participants Needed

1

Research Sites

366 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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. 3) To explore the possible indications of Plasmodium immunotherapy for advanced malignant solid tumors. The treatment will last 5-10 weeks from the day of successful infection and will be terminated by antimalarial drugs.

CONDITIONS

Official Title

Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-70 years, male or female
  • Diagnosed with advanced malignant solid tumors in lung, liver, prostate, ovary, brain, thyroid, colorectum, or primary CNS tumors meeting specific imaging and clinical criteria
  • Measurable tumors based on RECIST1.1 criteria
  • Tumor classification confirmed by histopathology with pathological reports provided
  • Acceptable tumor tissue samples available or alternative sample types if tumor tissue is unavailable
  • At least 28 days since last chemotherapy or radiotherapy, or appropriate washout periods for targeted therapies
  • ECOG score between 0 and 2, with ability to eat normally
  • Expected survival of 3 months or more
  • Adequate blood counts and albumin levels without significant anemia or red blood cell abnormalities
  • Resolved chronic bleeding symptoms before enrollment
  • No severe dysfunction of heart, lung, liver, or kidney functions (Child-Pugh grade A or B for liver, creatinine ≤1.5 x ULN)
  • Ability to understand and sign informed consent
  • Compliance judged adequate by researcher for follow-up
Not Eligible

You will not qualify if you...

  • Nasopharyngeal cancer or head and neck tumors
  • HPV-positive advanced malignant tumors in cervical, anal, vulvar, vaginal, or penile areas
  • Pancreatic cancer
  • Small cell lung cancer
  • Severe hemoglobin disease or severe G6PD deficiency
  • History of splenectomy or splenomegaly
  • Drug addiction or alcohol dependence
  • Not washed out from previous treatments except bisphosphonates
  • Uncontrolled pleural, pericardial effusion, or ascites
  • Uncontrollable tumor-related pain
  • Active malignant CNS metastases with progression or symptom control by anticonvulsants/corticosteroids
  • Significant immunodeficiency (CD4+ T cell count <200/µl)
  • Serious or unstable systemic diseases including infections, severe hypertension, heart failure, arrhythmia, liver/kidney dysfunction, neurological or psychiatric disorders
  • Other diseases or conditions judged by investigator to increase risk or affect study reliability
  • Major surgery within 4 weeks before screening or planned during study (excluding PICC or central venous catheter placement)
  • Receiving antineoplastic drugs, immune therapies, antibodies, or vaccines within five half-lives before screening
  • Prior allogeneic bone marrow or solid organ transplantation
  • Receiving other anti-tumor treatments concurrently
  • Severely impaired lung function or inability to get out of bed due to shortness of breath
  • Severe cough, dyspnea, poor diet, or difficulty cooperating
  • Poor physical condition making toleration of immunotherapy unlikely
  • Pregnant or breastfeeding women
  • Inability to comply with study and follow-up procedures
  • Any other conditions judged unsuitable by researchers for participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yunnan Kungang Hospital

Kunming, Yunnan, China, 650000

Actively Recruiting

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Research Team

Q

Qin Li, Ph.D

CONTACT

H

Huang Qiumei, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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