advanced solid tumors
Conditions
Interventions
Case series:Intratumoral injection of H101 combined with PD-1 antibody
Sponsors
The Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. Patients with advanced solid tumors confirmed by pathological examination had failed in standard treatment or had no effective standard treatment, and had no effective salvage treatment; 3. ECOG physical condition score is less than 2 points; 4. There is at least one target lesion which can be safely injected into the tumor. The diameter of the target lesion is more than 1 cm by spiral CT or 2 cm by conventional CT, and can be measured by imaging means; 5. Good organ function: ANC < 1.5 *10^9/L; WBC < 3 *10^9/L; PLT < 80 *10^9/L; Hb < 90 g/L; TBIL < 1.5 * ULN; ALT < 2.5 * ULN; ALB < 29 g/L; BUN < 1.5 * ULN; LVEF < 50%; 6. the estimated life cycle is more than 3 months; 7. the follow-up period must be at least greater than February; 8. be able to follow the research and follow-up procedures to provide real and effective information; 9. patients have the ability to understand and voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. kinds of biological agents allergic history; 2. All patients received any anti-tumor therapy (including radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy) within 4 weeks before the drug was administered; 3. patients who had previously received PD-1/PD-L1 inhibitors or oncolytic virus therapy; 4. women who are lactating and gestation, and those who cannot take contraceptive measures during the course of treatment; 5. there are clinically uncontrolled active infections; 6. there is a history of organ transplantation or other acquired or congenital immune diseases; 7. Any uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases); 8. cognitive ability and psychological abnormality; 9. Researchers believe that subjects may not be able to complete the study or may not be able to comply with the requirements of the study (due to management or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS;AEs; | — |
Countries
China
Contacts
Public ContactWANG Haitao
The Second Hospital of Tianjin Medical University
Outcome results
None listed