This is a Phase I/II, open, first-in-human (FIH) study of Transebacillus in Patients with malignant pleural and abdominal effusions. It consists of Phase Ia to determine the Maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) of Transebacillus, and Phase Ib/II to explore and confirm the efficacy, safety and Tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Tpdelansbsalbac,which is Knockdown of ansB, a gene that expresses L-mentholase secreted into the extracellular region, on the basis of the genetic background of bacterium VNP20009, and construction of an ansB gene-deficient mutant strain, ΔansB.
The First Affiliated Hospital of Xinxiang Medical university
Henan Province, China
RECRUITINGIncidence of Adverse event (AE)
Laboratory tests (blood routine test, infectious markers), electrocardiogram (ECG), echocardiogram (ECHO), Physical findings, changes in vital signs.
Time frame: 1 months
Puncture /drainage-Free Survival (PuFS)
Puncture /drainage-Free Survival (PuFS) was used as an index to evaluate the efficacy of intrathecal injection in the treatment of malignant pleural or abdominal effusions.
Time frame: 1 year
Phase Ia-Puncture /drainage-Free Survival (PuFS)
which was used as an index to evaluate the efficacy of intrathecal injection in the treatment of malignant pleural or abdominal effusions.
Time frame: 1 year
Phase Ib/II-Overall survival (OS)
the survival benefit of intravitreal injection of Transebacillus for the treatment of malignant thoracic or abdominal effusions as measured by overall survival
Time frame: 1 year
Objective remission rate (ORR) of pleural or abdominal effusion;
the objective remission rate of thoracic and abdominal effusions, the rate of no puncture and/or drainage at 3 months, and the time to next puncture and/or drainage (TTNP), as evaluated by the WHO Efficacy Criteria for Thoracic and Abdominal Fluids;
Time frame: 1 month
Time to next puncture and/or drainage (TTNP);
the change in symptoms and quality of life of subjects treated with intravitreal injections of Transebacillus for malignant thoracic or abdominal effusions, evaluated by changes in patient-reported outcome (PRO) scores before and after the intervention;
Time frame: 1 year
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3-month puncture and/or drainage free rate;
an index to evaluate the efficacy of intrathecal injection in the treatment of malignant pleural or abdominal effusions for 3 months
Time frame: 3 months
6-month and 12-month OS rates
an index to evaluate the overall survival of intrathecal injection in the treatment of malignant pleural or abdominal effusions for 6 months or 12 months
Time frame: 1 year
Quality of Life score(EORTC QLQ-C30 )
The quality of life consists of five function scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), which will evaluate the score of life quality. The larger the score obtained, the worse the quality of life.
Time frame: 1 year