Genital Neoplasms, FemalePhase 2NCT05051696
Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
A Phase 2 study testing H101 in people with Genital Neoplasms, Female, run by Liu Zi at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the effectiveness and safety of oncolytic viruses H101 intra-tumor injection combined with or without radiotherapy in refractory or recurrent gynecological malignancies. And further research the mechanism of oncolytic viruses H101. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genital Neoplasms, Female
- What is being tested?
- H101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2021to 30 Mar 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained.
- Age ≥ 18 years at the time of study entry.
- Histological or Cytologically diagnosed gynecological malignancies.
- Failure to prior standard treatment (surgery, chemotherapy, radiotherapy);
- Refractory/recurrence/metastasis gynecological cancer
- At least one measurable lesion according to the RECIST1.1.
- Cooperative Oncology Group-Status (ECOG Status) 0-3.
- The last treatment should be over 2 weeks.
Who cannot join
- History or evidence of active autoimmune disease that requires systemic treatment.
- Participated in other anti-tumor clinical trials within 4 weeks.
- Patients who have a contraindication to similar drugs.
- That failure to follow up regularly.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710061
About this study
The purpose of this clinical trial is to evaluate the effectiveness and safety of oncolytic viruses H101 intra-tumor injection combined with or without radiotherapy in refractory or recurrent gynecological malignancies. And further research the mechanism of oncolytic viruses H101.
Read the detailed description
Patients with recurrent, radiation/chemotherapy-resistant gynecological cancer carry a poor prognosis. H101 is a recombinant human type-5 adenovirus (Ad5), in which the E1B and E3 gene have been deleted. Previous studies have shown that H101 has anticancer activity and safety in some solid tumors, but has little report in gynecological oncology. In this clinical trial, 60 recurrent or refractory gynecological cancer patients will be enrolled. Based on individual conditions, all eligible patients are intra-tumor injected oncolytic viruses H101 within 5 consecutive days combined with or without radiotherapy in sequential, three weeks for a cycle (1-4 cycles totally). Simultaneously, the tumor sample, peripheral blood, and urine specimen were collected on day1 and day5. Local control rate and side effects are recorded respectively.
- Conditions
- Genital Neoplasms, Female
- Being tested
- H101
- Keywords
- Cervical Cancer, Ovary Cancer, Endometrial Cancer, Vaginal Neoplasms, Vulvar Neoplasms, H101
- Medical subject headings
- Genital Neoplasms, Female, Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H101Drug
Also called Radiotherapy
Intra-tumor injected oncolytic viruses H101 within 5 consecutive days,3 weeks for a cycle (1-4cycles)
| Study group | Role | What they receive |
|---|---|---|
| Oncorine (H101) with or without radiotherapy | Experimental | The tumor mass was injected with H101 per day for 5 consecutive days, 3 weeks as one treatment cycle, and 1 to 4 cycles according to the condition of the patient, and the patient was treated with or without radiotherapy in sequential. The injection dose of H101 was determined by the tumor volume or maximum tumor diameter:5.0×10^11 virus particles(VP) for if tumor diameter≤5cm; 1×10^12 VP for the tumor diameter between 5cm and 10cm, and 1.5×10^12 VP for the tumor diameter>10cm. Receives: Drug: H101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control (LC)
LC will be measured from the start date of injection until the date of progressive disease
Measured: 3 months
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR is the percentage of participants with presence of complete response (CR), partial response (PR). ORR assessment will be based on RECIST 1.1 criteria
Measured: 1 year after injection
Progress free survival (PFS)
Progress free survival is defined as the time from first day of injection until the first date of either objective disease progression or death due to any cause
Measured: 12 months
adverse events
Toxicity were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Measured: At day 3, 7 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start26 Sep 2021
- Primary completion30 Mar 2024
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genital Neoplasms, FemaleStudies of the same condition, open and under way.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liu Zi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Zi, Xi'an Jiaotong University
- Investigators
- Zi Liu, M.D, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051696
- Sponsor's protocol ID
- LZi
- Status last verified
- Jun 2024
- First submitted
- 11 Sep 2021
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-tumor Injection of Oncolytic Viruses H101 Combined With or Without Radiotherapy in Refractory/Recurrent Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT05051696
- Acronym / sponsor ID
- LZi
- Conditions
- Genital Neoplasms, Female
- Keywords
- Cervical Cancer, Ovary Cancer, Endometrial Cancer, Vaginal Neoplasms, Vulvar Neoplasms, H101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Liu ZiUniversity, hospital or other
- Study start
- 26 Sep 2021 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 21 Sep 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.
The purpose of this clinical trial is to evaluate the effectiveness and safety of oncolytic viruses H101 intra-tumor injection combined with or without radiotherapy in refractory or recurrent gynecological malignancies. And further research the mechanism of oncolytic viruses H101.
Detailed description
Patients with recurrent, radiation/chemotherapy-resistant gynecological cancer carry a poor prognosis. H101 is a recombinant human type-5 adenovirus (Ad5), in which the E1B and E3 gene have been deleted. Previous studies have shown that H101 has anticancer activity and safety in some solid tumors, but has little report in gynecological oncology. In this clinical trial, 60 recurrent or refractory gynecological cancer patients will be enrolled. Based on individual conditions, all eligible patients are intra-tumor injected oncolytic viruses H101 within 5 consecutive days combined with or without radiotherapy in sequential, three weeks for a cycle (1-4 cycles totally). Simultaneously, the tumor sample, peripheral blood, and urine specimen were collected on day1 and day5. Local control rate and side effects are recorded respectively.
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) with or without radiotherapy | Experimental | Drug: H101The tumor mass was injected with H101 per day for 5 consecutive days, 3 weeks as one treatment cycle, and 1 to 4 cycles according to the condition of the patient, and the patient was treated with or without radiotherapy in sequential. The injection dose of H101 was determined by the tumor volume or maximum tumor diameter:5.0×10^11 virus particles(VP) for if tumor diameter≤5cm; 1×10^12 VP for the tumor diameter between 5cm and 10cm, and 1.5×10^12 VP for the tumor diameter>10cm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent obtained.
- Age ≥ 18 years at the time of study entry.
- Histological or Cytologically diagnosed gynecological malignancies.
- Failure to prior standard treatment (surgery, chemotherapy, radiotherapy);
- Refractory/recurrence/metastasis gynecological cancer
Key exclusion criteria (4 listed)
- History or evidence of active autoimmune disease that requires systemic treatment.
- Participated in other anti-tumor clinical trials within 4 weeks.
- Patients who have a contraindication to similar drugs.
- That failure to follow up regularly.
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 |
|---|---|---|
| H101Also: RadiotherapyIntra-tumor injected oncolytic viruses H101 within 5 consecutive days,3 weeks for a cycle (1-4cycles) | Drug | Oncorine (H101) with or without radiotherapy |
Primary outcome
Local Control (LC)
Time frame: 3 months
LC will be measured from the start date of injection until the date of progressive disease
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 1 year after injection
Progress free survival (PFS)
Time frame: 12 months
adverse events
Time frame: At day 3, 7 and 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Zi Liu, M.D principal investigator
First Affiliated Hospital Xi'an Jiaotong 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 H101 in people with Genital Neoplasms, Female, run by Liu Zi 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 8 inclusion and 4 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 4 Jun 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 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?
Results are not available in the source record.
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?
Local Control (LC) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.