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| Name | Class |
|---|---|
| Eye & ENT Hospital of Fudan University | OTHER |
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9 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 relapsed/refractory head and neck cancer.
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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 in patients with relapsed/refractory head and neck cancer |
|
| 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 |
|---|---|---|
| Safety Profile Measured by Grade ≥3 CTCAE v5.0 | To characterize the safety profile of R130 injection in patients with relapsed/refractory head and neck cancer as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0) | Up to 6 months |
| 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 | 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:
Patients with head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment.
Age 18 to 75 years.
No absolute or relative centasis contraindiction,have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery.
No severe functinonal falure of heart, brain, liver, kidney and lung.
Subjects with ECOG score of 0-2, and expected survival of 3 months or more.
No evidence of clinically significant immunosuppression.
Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function during the screening period:
Be able to understand and sign the informed consent document;
Be able to stick to follow-up visit plan and other requirements in the agreement.
Exclusion Criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Pan, MD | Contact | +86 13764868528 | pf@jxyymedtech.com |
| Name | Affiliation | Role |
|---|---|---|
| Haitao Wu, Phd | Eye & ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital of Fudan University | Recruiting | Shanghai | 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 |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D004938 | Esophageal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D004428 | Ear Neoplasms |
| D009669 | Nose Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D004427 | Ear Diseases |
| D012888 | Skull Neoplasms |
| D001859 | Bone Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D007818 | Laryngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D050130 | Oncolytic Virotherapy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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