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Malignant AscitesPhase 1NCT06200376

A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer

A Phase 1 study testing T3011 in people with Malignant Ascites, run by West China Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, open, single-arm, investigator-initiated clinical study to evaluate the safety and efficacy of intraperitoneal administration of T3011 at different doses in the treatment of malignant ascites induced by advanced colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Ascites
What is being tested?
T3011
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
28 Sep 2023to Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female age ≥ 18 years and ≤ 75 years at the time of informed consent.
  • Histologically or cytologically confirmed advanced unresectable or metastatic colorectal cancer;
  • Anticipated life expectancy ≥3 months
  • Associated with medium amount of malignant ascites (defined as the amount of ascites ≥3cm by B ultrasonography in lying position accompanied by clinical symptomes like abdonimal distension and cytology tests possitive for tumor in ascites); No paracentesis performed with 28 days before first dosing; and the ascites can not be controlled by SOC according to PI judgement.
  • ECOG performance status 0-2 (including threshold);
  • Weight ≥40kg
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  • Hematology:
  • White blood cell (WBC) ≥ 3.0×10^9/L;
  • Neutrophil (ANC) ≥ 1.5×10^9/L;
  • Platelet (PLT) ≥ 75×10^9/L;
  • Hemoglobin (Hb) ≥ 8.0g/dL
  • Hepatic and renal function:
  • Total bilirubin ≤ 1.5 × ULN;
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN for patient without liver metastasis, ≤ 5 × ULN for patients with liver metastasis;
  • Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min as determined by the Cockcroft-Gault equation;
  • Abumin≥30 g/L
  • Coagulation:
  • INR≤1.5 x ULN;
  • APTT≤1.5 x ULN;
  • For women of childbearing potential (WCBP), serum pregnancy test should be negative within 14 days before dosing. WCBP patients, as well as male patients with partners of WCBP, should consent to use at least one medically approved contraceptive method (e.g. surgical sterilization, oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) during the study and for at least 6 months after the last dosing;
  • Willingness to attend this study, to sign informed consent, to have good compliance, and to cooperate with follow-up visit.

Who cannot join

  • Previously diagnosed with decompensated cirrhosis, and with portal vein and branch involvement or cancer embolus;
  • Pregnant or lactating, or plan to pregnant or give birth during the trial;
  • Persistent or active infection that are not controlled by treatment including but not limited to: active tuberculosis, non-negative HIV antibody, HBsAg positive and HBV DNA ≥LOQ, HCV ab positive and HCV DNA ≥LOQ;
  • Patients with imageological confirmed brain metastasis or brain metastasis history (except patients with stable disease within 3 months before screening and not require systemic glucorticoid therapy according to PI), pia meningeal disease, spinal cord compression;
  • Autoimmune disease or related symptoms, or previously suffered from autoimmune disease;
  • History of splenectomy or organ transplantation;
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  • Prior treatment with Oncolytic virus (OV) (including but not be limited to T-VEC, T3011), gene therapy, cellular therapy or tumor vaccines;
  • Requires oral or intravenous therapy against herpes virus (including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir). Topical use of drugs (eg. external use) are allowed;
  • Patients are scheduled to receive other therapy against malignant ascites (including but not limited to chemotherapy, target therapy, immunotherapy), and the best supportive treatment for malignant ascites is permitted (e.g., albumin supplements, etc.);
  • Patients with a known psychiatric disorder that would interfere with cooperation with the requirements of the trial;
  • History of narcotics (recreational use) and substance abuse (including alcohol) within 1 year prior to signing informed consent;
  • History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody or any excipients for T3011;
  • History or evidence of high risk cardiovascular disease, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, QT interval corrected using the Fridericia formula (QTcF) ≥ 450 msec (male) or ≥ 470 msec (female);
  • Acute myocardial infarction, unstable angina pectoris, or stroke occurred within 6 months before the first administration of the experimental drug;
  • Coronary angioplasty or stent implantation within 6 months prior to first administration of the experimental drug;
  • Rating of heart function as defined by the New York Heart Association (NYHA) standards>grade II; Cardiac valve abnormalities recorded by echocardiography (≥ grade 2). Note: Subjects with grade 1 cardiac valve abnormalities (such as mild regurgitation/stenosis) were admitted, but subjects with moderate valve thickening were excluded;
  • Left ventricular ejection fraction (LVEF) < the center lower limit. If no lower limit existed, LVEF<50%;
  • Poor blood pressure control after antihypertensive treatment (i.e. systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
  • History of another malignant tumor, except the following:
  • Undergo potentially curative therapy and for ≥5 years prior to the first dose of study treatment and no malignancies with known active disease and low potential recurrence risk;
  • Adequately treated non-melanoma skin cancer or lentigo with no evidence of malignancy;
  • Adequately treated carcinoma in situ without evidence of disease;
  • Received live and attenuated vaccines within 4 weeks prior to initiation of study treatment, or plan to be vaccined during the study;
  • Previous history of immunotherapy induced non-infectious pneumonitis/ interstitial lung disease (including but not limited to ≥3 grade irAE) or intolerance to immunotherapy (including but not limited to anti-PD-(L)1 monoclonal Ab), except endocrine-related irAE that can be stably controlled by hormone replacement therapy;
  • Unexplained >38.5℃ fever (except for tumor induced fever judged by PI) occurs during the screening period, baseline period or on the day of administration, which in the judgment of investigator, would interfere with patient participation in the study or patient's efficacy evaluation;
  • Any condition that PI considered may confuse the trial results, interfere with the participant's participation in the trial, or is not in the participant's best interest to participate in the trial, or a history of treatment or laboratory abnormalities, or other ineligibility for enrollment

Trial locations and contacts

1 site in 1 country.

Meng Qiu, MD contact

028-85423203

qiumeng33@hotmail.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    Meng Qiu, MD, 028-85423203, qiumeng33@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study of Safety and Efficacy of T3011 Administered Via Intraperitoneal Injection as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer

This is a prospective, open, single-arm, investigator-initiated clinical study to evaluate the safety and efficacy of intraperitoneal administration of T3011 at different doses in the treatment of malignant ascites induced by advanced colorectal cancer.

Being tested
T3011

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T3011Drug

    T3011 will be administered intraperitoneally twice a week.

Study groups in NCT06200376
Study groupRoleWhat they receive
T3011ExperimentalNot described
Receives: Drug: T3011

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse event

    To evaluate the safety of intraperitoneal T3011 in the treatment of patients with malignant intraperitoneal ascites

    Measured: 28 days after EOT

Secondary outcomes (5)

  1. Overall response rate (ORR)

    To evaluate the ORR of intraperitoneal T3011 in the treatment of patients with malignant intraperitoneal ascites using B ultrasonography and CT scan

    Measured: From 4th dosing to disease progression, consent withdraw, death or end of study, assessed up to 24 months

  2. Disease control rate (DCR)

    To evaluate the DCR of intraperitoneal T3011 in the treatment of patients with malignant intraperitoneal ascites using B ultrasonography and CT scan

    Measured: From 4th dosing to disease progression, consent withdraw, death or end of study, assessed up to 24 months

  3. Time to onset of therapeutic paracentesis

    To evaluate the effect of intraperitoneal T3011 on the interval of therapeutic abdominal paracentesis in patients with malignant ascites

    Measured: From 4th dosing to disease progression, consent withdraw, death or end of study, assessed up to 24 months

  4. Overall survival (OS)

    To evaluate the OS of intraperitoneal T3011 in the treatment of patients with malignant intraperitoneal ascites

    Measured: Up to 24 months

  5. Quality of life questionnaire (QLQ-C30)

    The EORTC Core Questionnaire (QLQ-C30) is widely used to measure quality of life in oncology. For self-reported general health and psychological distress, a higher score indicated worse health.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start28 Sep 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06200376
Sponsor's protocol ID
MVR-T3011-ES-EC61-MA
Status last verified
Dec 2023
First submitted
12 Oct 2023
Last updated
11 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing T3011 in people with Malignant Ascites, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Meng Qiu, MD (028-85423203, qiumeng33@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event (time frame: 28 days after EOT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06200376.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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