Solid tumors with high alpha-fetoprotein expression
Conditions
Interventions
group B:SynOV1.1 combined with PD-1/VEGF antibody
group A:SynOV1.1
Sponsors
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in clinical research; Fully informed and informed of this study; Willing to follow and able to complete trial procedures. 2. Age 18~80 (inclusive) years old. 3. Patients with solid tumors with clinical judgment that is AFP positive (AFP > 20 µg/L). 4. At least one lesion that can be injected directly or by imaging-guided real-time intratumoral injection with imaging examination three-phase CT scan or dynamic control enhanced MRI image revealing: 10 mm = 12 weeks. 7. Have adequate organ function: (1) Hematological system: absolute neutrophil value (ANC) > = 1.5 x 10^9/L; Platelets (PLT)> = 60 x 10^9/L; Hemoglobin (Hb)> = 90 g/L. (2) Liver function: total bilirubin (TBIL) = 2.8 g/dL. (3) Renal function: creatinine = 50 mL/min (calculated according to the Cockcroft-Gault formula, Ccr calculated only when creatinine > 1.5 x ULN). (4) Coagulation function: activated partial thromboplastin time (aPTT) <= 1.5 x ULN; International normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN. (5) Thyroid function: thyroid-stimulating hormone (TSH)<= 3 x ULN; Free thyroxine (FT3/FT4) < = 1 x ULN. (6) Child-Pugh liver function score of grade A or better grade B (<= 7 points). 8. Evidence of postmenopausal status in female patients or negative serum pregnancy test in premenopausal female patients. 9. Eligible subjects of childbearing potential (male and female) must agree to use effective birth control (hormonal or barrier method or abstinence) with their partner during the trial and for at least 90 days after the last dose.
Exclusion criteria
Exclusion criteria: 1.Patients must have received any systemic anti-tumor therapy, including but not limited to chemotherapy, biotherapy, immunotherapy, targeted therapy, or hormone therapy, within 3 weeks or at least 5 drug half-lives (whichever is shorter) prior to the first use of the investigational drug; and patients must have received any local treatment or surgery targeting the lesion, including ethanol injection, radiofrequency ablation, transarterial chemoembolization, or intrahepatic artery chemotherapy, within 4 weeks prior to the first use of the investigational drug. 2.Patients who have received systemic glucocorticoids (prednisone >10 mg/day or equivalent dose of the same drug) or other immunosuppressants within 14 days prior to the first use of the study drug; excluding the following: use of topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., for contrast agent allergy prevention). 3.Patients who have used immunomodulatory drugs, including but not limited to thymosin, interleukin-2, and interferon, within 14 days prior to their first use of the investigational drug. 4.Administered live attenuated vaccines within 4 weeks prior to the first use of the investigational drug, including but not limited to: measles, mumps, rubella, varicella/shingles, yellow fever, rabies, BCG, and typhoid vaccines. Injectable seasonal influenza vaccines are inactivated virus vaccines and are therefore permitted; intranasal influenza vaccines are live attenuated or non-live attenuated vaccines and are not permitted. 5.The patient had received treatment with other unmarketed investigational drugs within 4 weeks prior to the first use of the investigational drug. 6.Simultaneous enrollment in another clinical study, except for the follow-up phase of an observational (non-interventional) clinical study or an interventional study. 7.Those who have undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first use of the investigational drug, or who need to undergo elective surgery during the trial. 8.Adverse reactions to previous antitumor treatments have not recovered to grade 1 (=1 in NCI-CTCAE V5.0 rating, excluding toxicities such as hair loss that researchers judged to pose no safety risk). 9.Patients with clinically symptomatic central nervous system or meningeal metastases, or other evidence indicating that these metastases are uncontrolled, and deemed unsuitable for enrollment by the investigator, or whose clinical symptoms suggest brain or meningeal disease, require CT/MRI examination for exclusion. Patients with previously treated brain metastases who are clinically stable for 4 weeks prior to enrollment and have no evidence of new lesions or lesion enlargement, and who have not received steroid treatment within 7 days prior to the first dose, may be considered for enrollment. 10.Has a history of leptomeningeal disease. 11.There is evidence of uncontrolled serious comorbidities that could affect patient adherence to the study protocol, including serious liver disease (such as severe esophageal and gastric varices requiring intervention, hepatic encephalopathy, or superior vena cava syndrome). 12.A history of severe cardiovascular disease, including but not limited to: severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventric
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of DLT occurrence;Adverse Event (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Injection lesion tumor size; | — |
Countries
China
Contacts
Public ContactNing Li
Langfang Campus of Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed