Refractory Malignant AscitesPhase 2NCT04771676
Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites
A Phase 2 study testing Oncorine (H101) in people with Refractory Malignant Ascites, run by Fudan University at 1 site in China.
Trial summary
Assessment of effectiveness, safety and local immune activation of Oncolytic Viruses H101 in patients with refractory malignant ascites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Malignant Ascites
- What is being tested?
- Oncorine (H101)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2021to 31 Jan 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained.
- Age ≥ 18 years at time of study entry.
- Histologically diagnosed solid tumor malignancy.
- Malignant peritoneal ascites confirmed by cytologic examination.
- Failures from chemotherapy or other anti-cancer therapy or standard chemotherapy was no longer feasible.
- Cooperative Oncology Group-Status (ECOG Status) ≤ 2.
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- life expectancy >8 weeks
- Estimated ascites volume >1 L by CT scan.
- At least one symptomatic paracentesis within 4 weeks as well as an objectively verified, clinical need for a second paracentesis
- Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/uL, platelets ≥60 x103u/L; Total bilirubin ≤ 3 x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula).
- Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.
Who cannot join
- History or evidence of active autoimmune disease that requires systemic treatment.
- Acute or chronic active Hepatitis B or C infection or HIV infection.
- Previous (<4 weeks) or concurrent treatment with systemic or intraperitoneal chemotherapy or biological agents such as monoclonal antibodies.
- Concurrent severe illness such as active infection.
- Enteral feeding at study entry.
- Ileus within the previous 30 days
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- >70% tumor infiltration of the liver or portal vein obstruction.
- Arterial or venous thromboembolic disease.
- Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
- Known acute or chronic pancreatitis
- Active tuberculosis
- Any other active infection (viral, fungal or bacterial) requiring systemic therapy
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study.
- History or clinical evidence of Central Nervous System (CNS) metastases. Exceptions for subjects who have completed local therapy. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.
- Medication that is known to interfere with any of the agents applied in the trial.
- Any other efficacious cancer treatment except protocol specified treatment at study start.
- Patient has received any other investigational product within 28 days of study entry.
- Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year).[Acceptable methods of contraception are implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.
- Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year).[Acceptable methods of contraception are implants, injectable contraceptives, combine d oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner]. Women of childbearing potential must have a negative pregnancy test (serum β-HCG) at screening.
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites
Assessment of effectiveness, safety and local immune activation of Oncolytic Viruses H101 in patients with refractory malignant ascites.
Read the detailed description
This study is to evaluate the effectiveness of local immune activation, and safety in patients with refractory malignant ascites after Intraperitoneal injection of oncolytic Viruses H101.
- Conditions
- Refractory Malignant Ascites
- Being tested
- Oncorine (H101)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncorine (H101)Drug
A modified human recombinant type 5 adenovirus with genetic modifications.
| Study group | Role | What they receive |
|---|---|---|
| Oncorine (H101) | Experimental | H101 diluted in 5ml 0.9% sodium chloride solution will be intraperitoneally injected through the drainage catheter. Each patient will receive a dose of 1.5×10^12 vp by i.p. administration on day 1 and 3. Receives: Drug: Oncorine (H101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to repeat paracentesis (TTRP)
Defined as the number of days between the first paracentesis (baseline) and the subsequent repeat paracentesis.
Measured: max 6 months
Secondary outcomes (5)
Analysis of adverse events
Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of H101 will be recorded
Measured: max 6 months
Paracentesis free survival (PaFS)
Difined as the time from the date of first paracentesis to the repeat paracentesis or death.
Measured: max 6 months
60-day frequency of paracentesis
Defined as frequency of paracentesis during the first 60 days.
Measured: max 6 months
Overall survival (OS)
Defined as the time from the date of patient enrollment until the date of death from any cause.
Measured: max 6 months
Change from baseline local and systemic immune effects after H101 intraperitoneal injections
Detection of immune activation in malignant ascites and blood will be assessed by single cell sequencing and Mass Cytometry (CyTOF).
Measured: at baseline, 3-, 7, 14 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start5 Mar 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory Malignant AscitesStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Wang, Fudan University
- Investigators
- Peng Wang, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771676
- Sponsor's protocol ID
- 2012229-11
- Status last verified
- Jan 2023
- First submitted
- 22 Feb 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang Y, Qian L, Chen K, Gu S, Meng Z, Wang J, Li Y, Wang P. Oncolytic adenovirus in treating malignant ascites: A phase II trial and longitudinal single-cell study. Mol Ther. 2024 Jun 5;32(6):2000-2020. doi: 10.1016/j.ymthe.2024.04.029. Epub 2024 Apr 24.
PubMed 38659226
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites
- ClinicalTrials.gov ID
- NCT04771676
- Acronym / sponsor ID
- 2012229-11
- Conditions
- Refractory Malignant Ascites
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of effectiveness, safety and local immune activation of Oncolytic Viruses H101 in patients with refractory malignant ascites.
Detailed description
This study is to evaluate the effectiveness of local immune activation, and safety in patients with refractory malignant ascites after Intraperitoneal injection of oncolytic Viruses H101.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncorine (H101) | Experimental | Drug: Oncorine (H101)H101 diluted in 5ml 0.9% sodium chloride solution will be intraperitoneally injected through the drainage catheter. Each patient will receive a dose of 1.5×10^12 vp by i.p. administration on day 1 and 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent obtained.
- Age ≥ 18 years at time of study entry.
- Histologically diagnosed solid tumor malignancy.
- Malignant peritoneal ascites confirmed by cytologic examination.
- Failures from chemotherapy or other anti-cancer therapy or standard chemotherapy was no longer feasible.
Key exclusion criteria (20 listed)
- History or evidence of active autoimmune disease that requires systemic treatment.
- Acute or chronic active Hepatitis B or C infection or HIV infection.
- Previous (<4 weeks) or concurrent treatment with systemic or intraperitoneal chemotherapy or biological agents such as monoclonal antibodies.
- Concurrent severe illness such as active infection.
- Enteral feeding at study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncorine (H101)A modified human recombinant type 5 adenovirus with genetic modifications. | Drug | Oncorine (H101) |
Primary outcome
Time to repeat paracentesis (TTRP)
Time frame: max 6 months
Defined as the number of days between the first paracentesis (baseline) and the subsequent repeat paracentesis.
5 secondary outcomes
Analysis of adverse events
Time frame: max 6 months
Paracentesis free survival (PaFS)
Time frame: max 6 months
60-day frequency of paracentesis
Time frame: max 6 months
Overall survival (OS)
Time frame: max 6 months
Change from baseline local and systemic immune effects after H101 intraperitoneal injections
Time frame: at baseline, 3-, 7, 14 days after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 38659226Zhang Y, Qian L, Chen K, Gu S, Meng Z, Wang J, Li Y, Wang P. Oncolytic adenovirus in treating malignant ascites: A phase II trial and longitudinal single-cell study. Mol Ther. 2024 Jun 5;32(6):2000-2020. doi: 10.1016/j.ymthe.2024.04.029. Epub 2024 Apr 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Wang, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oncorine (H101) in people with Refractory Malignant Ascites, run by Fudan University 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 12 inclusion and 20 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: finished, as of the sponsor's last update on 31 Jan 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to repeat paracentesis (TTRP) (time frame: max 6 months). 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 NCT04771676, which also lists 1 linked publication.
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 31 Jan 2023.