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| Name | Class |
|---|---|
| Linyi People's Hospital | OTHER |
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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 â… , R130 in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R130 Treatment Group | Experimental | Every 7-14 days,1-2 ml R130 (concentration of 1x10^8 plaque-forming Units/mL,PFU/mL)will be injected intratumoral or intraperitoneal in patients with advanced solid tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant oncolytic herpes simplex virus type 1 (R130) | Drug | R130, a modified herpes simplex virus-â… (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject incidence of adverse events | To characterize the safety profile of R130 injection in patients with advanced solid tumors as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0),such as fever, fatigue, flu like symptoms, chills, Injection site reaction,etc. | Up to 6 months |
| Subject incidence of laboratory abnormalities | Up to 1 month | |
| Systemic Immune Response | Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa,IFNγ, etc.) 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 | CT will be performed to evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST. DCR (proportion of patients) = with CR +PR +SD /CR + PR +SD + PD. | 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 | Contact | +8613764868528 | pf@jxyymedtech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linyi Central Hospital | Recruiting | Linyi | Shandong | 276000 | China |
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|
The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1 |
| Every 10 weeks for 12 months |
| Quality of Life Assessment | Comparison of patients' quality of life before and after R130 treatment as assessed by the EORTC QLQ-30 (V3.0). | Every 6 weeks for 12 months |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D002277 | Carcinoma |
| D005770 | Gastrointestinal Neoplasms |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D001932 | Brain Neoplasms |
| D008545 | Melanoma |
| D006258 | Head and Neck Neoplasms |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D050130 | Oncolytic Virotherapy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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