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| Name | Class |
|---|---|
| Shanghai 10th People's Hospital | OTHER |
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10 participants are expected to be enrolled for this open,Single-armed clinical trial to evaluate the safety, tolerability, and efficacy of the recombinant herpes simplex virus I, R130 in patients with relapsed/refractory ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R130 Treatment Group | Experimental | Every 7-14 days,1-4 ml R130 (concentration of 1x10^6-1x10^8 plaque-forming Units/mL,PFU/mL)will be injected intratumoral or Intraperitioneal in patients with relapsed/refractory ovarian cancer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant oncolytic herpes simplex virus type 1 (R130) | Drug | R130, a modified herpes simplex virus-1 (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 months |
| 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) | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Assessment for Disease Control Rate | Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST | Every 10 weeks for 12 months |
| Disease Assessment for Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Pan, MD | Contact | +86 13764868528 | pf@jxyymedtech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
| Every 10 weeks for 12 months |
| Quality of Life Assessment | Evaluate with EORTC QLQ-C30 | Every 6 weeks for 12 months |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D005184 | Fallopian Tube Diseases |
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