ClinicalTrials.gg
RecruitingNCT06178003Updated Jan 29, 2024

the Safety and Efficacy of Intravitreal Injection of Tpdelansbsalbac in Malignant Effusions.

An interventional study of Tpdelansbsalbac in Salmonella Bacteremia, sponsored by The First Affiliated Hospital of Xinxiang Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by The First Affiliated Hospital of Xinxiang Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Salmonella Bacteremia

Browse trials for

Keywords

  • malignant pleural and abdominal effusions
  • Salmonella Bacteremia
03

In context

Bacteremia

297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.

This study's planned enrollment of 65 is below the median of 156 across 156 interventional studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

The First Affiliated Hospital of Xinxiang Medical College is the lead sponsor of 42 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Voluntarily participate, sign the , and good compliance, able to cooperate with the diagnosis and treatment and follow-up;
  • Age ≥18 years old (inclusive), male and female are not limited;
  • Malignant solid tumors other than primary hepatocellular carcinoma confirmed by pathological histological or cytological examination;
  • Malignant thoracic/abdominal effusion patients who have failed at least one standard antitumor systemic therapy, are not suitable for standard systemic therapy, or have no standard systemic therapy. The pleural/abdominal effusion needs to be confirmed pathologically (malignant cells found in the cytosol or pathological changes of observed in the pleural/peritoneal tissue) or clinically diagnosed as malignant pleural/abdominal effusion;
  • A pleural/peritoneal effusion of intermediate or greater volume confirmed by ultrasound, which in clinical judgment requires localized treatment of the pleural/ peritoneal effusion; definition of intermediate or greater volume: maximum depth of pleural effusion ≥ 3 cm by ultrasound in sitting position; or maximum depth of abdominal effusion ≥ 4 cm by ultrasound in lying position;
  • score ≥ 60;
  • Expected survival ≥ 3 months;
  • Major organ function is essentially normal and laboratory tests;
  • Screening female subjects of with a negative serum pregnancy test; female/male subjects of childbearing potential must be willing to use a reliable method of throughout the study period (i.e., from the time of signed informed consent to 90 days after the last dose of study medication), including, but not limited to, abstinence, a male partner who has undergone a vasectomy, female sterilization, an effective intrauterine device, and effective contraceptives.
  • Patients are willing to participate in the study, sign an informed consent form, and have good compliance.

Exclusion criteria

Exclusion Criteria:

  • Participating in or has participated in another clinical trial with therapy within 4 weeks prior to first dose, or has participated in a device clinical trial within 4 weeks;
  • has received systemic antitumor therapy or a drug in the thoracic-abdominal cavity within 14 days of the first intratumoral administration;
  • less than 4 weeks since the need for re-puncture/drainage due to progression of the effusion after having received intraluminal therapy with cisplatin and/or an anti-angiogenic drug (e.g., Endo, bevacizumab, etc.) for the thoracic-abdominal effusion that is the subject of the treatment planned for this study;
  • Has not recovered from any intervention-induced adverse event ≤ Grade 1 (except for hair loss, hearing impairment, and neurologic or endocrine disorders ≤ Grade 2 requiring replacement therapy) prior to the first dose;
  • Subjects who have undergone a medium to major surgical procedure other than diagnostic or within 28 days prior to the first dose, or who are expected to undergo a major surgical procedure during the study period;
  • Bilateral pleural effusion (for patients with pleural effusion) or concomitant thoracoabdominal effusion (non-enrolled treatment cavities that have not reached a moderate volume of effusion and, in the judgment of the investigator, are in stable condition and do not require clinical management may be considered for enrollment), or pericardial effusion (more than a moderate volume or with associated symptoms that, in the judgment of the investigator, require treatment) or an encapsulated effusion or celiac disease on the side of the planned treatment or have undergone within 14 days prior to the first administration of the study medication Therapeutic puncture and/or drainage (presence of suspected symptoms of effusion as well as previous history of effusion, B-ultrasound is required during the Screening Period to confirm the amount of effusion in the non-enrolled treatment cavity);
  • Comorbid severe (global initiative for chronic obstructive lung disease (GOLD) ≥ 3), intestinal adhesions within 6 months prior to the first dose (except in patients with pleural effusions in the treatment cavity) or intestinal obstruction within 6 months prior to the first dose. Bowel obstruction within 6 months prior to the first dose;
  • Severe cardiovascular disease such as (NYHA) heart disease (Class III rating or better) or myocardial infarction within 6 months or current unstable angina pectoris or uncontrolled hypertension (systolic blood pressure greater than 150 mmHg and/or diastolic blood pressure greater than 100 mmHg);
  • Patients with uncontrolled primary brain tumors or with significant intracranial hypertension or neuropsychiatric symptoms;
  • Presence of uncontrolled neuropsychiatric disease, psychiatric disorders, or substance abuse that may affect compliance with the trial;
  • The presence of an uncontrollable neuropsychiatric disease, psychiatric disorder, or substance abuse that may interfere with trial compliance;
  • Presence of an active infection requiring systemic therapy;
  • A known history of (HIV) infection;
  • virus-infected patients (HBsAg-positive or HBcAb-positive with HBV-DNA ≥2000 IU/mL or HBV-DNA ≥104 copies/mL), or virus-infected patients (HCV antibody-positive with HCV-RNA quantitative test results greater than the lower limit of detection); Note: For HBV-DNA \<2000 IU/mL Note: Hepatitis B virus-infected patients with HBV-DNA \<2000 IU/mL or HBV DNA \<104 copies/mL may be enrolled if they are willing to be treated with entecavir, tenofovir, or other antiviral therapy during the study period based on clinical judgment;
  • Individuals who are allergic to any active or inactive ingredient of entrectal or co-administered chemotherapeutic agents;
  • Pregnant or lactating female patients;
  • Use of antibiotic drugs with caution;
  • Presence of medical history or disease, therapeutic or laboratory abnormality that has the potential to interfere with the results of the trial, to prevent the subject from participating in the study in its entirety, or where participation in the study is not, in the opinion of the investigator, in the best interest of the subject.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Experimental
    intravitreal injection of Tpdelansbsalbac in malignant pleural and abdominal effusions

    the safety and efficacy of intravitreal injection of Tpdelansbsalbac in the treatment of malignant pleural and abdominal effusions

    Biological: Tpdelansbsalbac

Interventions

  • BiologicalTpdelansbsalbac

    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.

06

What researchers measure

Primary outcomes

  1. Incidence 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. 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

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Xinxiang Medical university
    Henan Province, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06178003
Lead sponsor
The First Affiliated Hospital of Xinxiang Medical College
Responsible party
Sponsor
First posted
Dec 20, 2023
Start date
Feb 11, 2024 (estimated)
Primary completion
Apr 1, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Jan 29, 2024

Study contacts

Yinghua Ji
Contact
54234317@qq.com
13663030446

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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