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Status unknownNCT05812677Updated Apr 14, 2023

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Cervical and Endometrial Cancer

An Early Phase 1 interventional study of Recombinant oncolytic herpes simplex virus type Ⅰ (R130) in Cervical Cancer, Endometrial Cancer and Advanced Cancer, sponsored by Shanghai Yunying Medical Technology. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by Shanghai Yunying Medical Technology · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

20 participants are expected to be enrolled for this open,Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory Cervical and Endometrial Cancer.

02

Conditions studied

  • Cervical Cancer
  • Endometrial Cancer
  • Advanced Cancer

Keywords

  • Oncolytic virus
  • Herpes simplex virus typeⅠ
  • Immunotherapy
03

In context

Uterine Cervical Neoplasms

1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Shanghai Yunying Medical Technology is the lead sponsor of 8 studies on the registry; 6 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
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

  1. Patients with cervical cancer or endometrial cancer clearly diagnosed by histology and/or cytology.
  2. Failure of standard treatment or patient unwillingness to receive other antitumor therapy.
  3. Age 18 to 75 years.
  4. Subjects with ECoG score of 0-2.
  5. Expected survival of 3 months or more.
  6. Have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral or intraperitoneal drug delivery.
  7. Subjects must have appropriate organ function, and laboratory tests during the screening period must meet the following requirements: a) absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets (PLT) ≥ 80 × 109/L, and hemoglobin (Hb) ≥ 85 g/L; b) serum creatinine (Cr) and blood urea nitrogen (BUN) within 1.5 times the upper limit of normal values; c) serum c) serum total bilirubin (TBIL) ≤ 2 times the upper limit of normal values; d) glutamic aminotransferase (ALT) and glutamic oxalacetic aminotransferase (AST) ≤ 2.5 times the upper limit of normal values; subjects with liver metastases do not exceed 5 times the upper limit of normal values; e) activated partial thromboplastin time (APTT), prothrombin time (PT) within 1.5 times the upper limit of normal values.
  8. Any treatment for malignancy, including radiotherapy, chemotherapy and biological agents, must be discontinued 28 days prior to R130 treatment.
  9. Eligible patients of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for the duration of the trial and for at least 180 days after the last dose; female patients of childbearing potential must have a negative urine pregnancy test within 7 days prior to enrollment.
  10. Subjects voluntarily sign an informed consent form and are in good compliance.

Exclusion criteria

Exclusion Criteria:

  1. Have had any serious adverse reactions associated with immunotherapy.
  2. Subjects with any severe and/or uncontrolled disease, including: a) poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); b) suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification > 1.0 g.
  3. Patients with past history of type I diabetes mellitus or HIV.
  4. Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy.
  5. Patients with symptomatic primary or metastatic brain tumors.
  6. Patients with active tuberculosis and a strong positive OT test.
  7. Patients with active bleeding or severe coagulation dysfunction.
  8. Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy, 4 weeks prior to the first dose.
  9. Have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy.
  10. Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.
  11. Patients who have undergone surgery of grade 3 or higher or whose surgical wounds have not healed within 4 weeks prior to enrollment.
  12. Participation in other clinical trials within four weeks prior to enrollment.
  13. Subjects who, in the judgment of the investigator, are unsuitable for participation in this trial for any reason.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    R130 Treatment Group

    Every 7-14 days,1-4 ml R130 (concentration of 1x10\^8 plaque-forming Units/mL,PFU/mL)will be injected intratumoral or Intraperitioneal in patients with relapsed/refractory cervical and endometrial Cancer.

    Drug: Recombinant oncolytic herpes simplex virus type Ⅰ (R130)

Interventions

  • DrugRecombinant oncolytic herpes simplex virus type Ⅰ (R130)

    Drug pages: Oncolytic HSV-1 R130 · Tetrachloroethane

    R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11

    Also known as: Oncolytic virus Injection

06

What researchers measure

Primary outcomes

  1. Adverse Events

    All serious and non-serious adverse events that occur after enrollment through 7 (+14) days after the last administration of R130 will be recorded

    Time frame: Up to 6 months

  2. Systemic immune response

    Detection of increased systemic immune Response markers in sera,ascites and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)

    Time frame: Up to 6 months

Secondary outcomes

  1. Disease Assessment for Disease Control Rate

    Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST

    Time frame: Every 10 weeks for 12 months

  2. Disease Assessment for Duration of Response

    Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST

    Time frame: Every 10 weeks for 12 months

  3. Quality of Life Assessment

    Evaluate with EORTC QLQ-C30

    Time frame: Every 6 weeks for 12 months

07

Study locations

1 of 1 sites recruiting
  • Shanghai Tenth People's Hospital
    Shanghai, Shanghai Municipality 200000, China
    • Jing Guo, Phd · Contact · jguo12@foxmail.com · +86 18817821547
    • Zhongping Cheng, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Feb 2025, 24 months after the start.

Of 98 phase 1 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 100. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2023
First posted
Apr 14, 2023
StartActual
Feb 6, 2023
Primary completionEst.
Feb 6, 2025
CompletionEst.
Feb 6, 2026
Last update
Apr 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05812677
Lead sponsor
Shanghai Yunying Medical Technology
Responsible party
Sponsor
First posted
Apr 14, 2023
Start date
Feb 6, 2023
Primary completion
Feb 6, 2025 (estimated)
Completion
Feb 6, 2026 (estimated)
Last update
Apr 14, 2023

Study contacts

Feng Pan
Contact
pf@jxyymedtech.com
+86 13764868528

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Oncolytic HSV-1 R130 · Tetrachloroethane

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