Recurrent or metastatic solid tumors
Conditions
Interventions
Experimental group:QYK-101 biological products for injection combined with radiotherapy
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–80 years, male or female; 2.ECOG performance status score of 0–2; 3.Histologically confirmed recurrent or metastatic solid tumors (including but not limited to pancreatic cancer, colorectal cancer, lung cancer, liver cancer, cholangiocarcinoma, gastrointestinal stromal tumor, lymphoma, head and neck cancer, gastric cancer, bone and soft tissue sarcoma, neuroendocrine tumor, etc.) that have progressed under standard therapy, or for which the patient has refused, is intolerant of, or lacks effective standard therapy; 4.At least one measurable lesion according to RECIST 1.1; for patients with brain metastases, at least one extracranial metastatic lesion is required; at least one lesion suitable for >=5 Gy/f radiotherapy and intratumoral injection (as determined by the investigator); 5.Estimated life expectancy >=12 weeks; 6.Adequate major organ and bone marrow function, meeting all of the following: (1) Hemoglobin>=80 g/L (without blood transfusion in the past 14 days); (2) Absolute neutrophil count >=1.5 × 10^9/L; (3) Platelet count >=90 × 10^9/L; (4) Total bilirubin =50%; (8) For patients not on anticoagulation therapy: INR =1 cycle for radiotherapy, >=5 half-lives for systemic anticancer drugs (chemotherapy, targeted therapy, immunotherapy, etc.); (10) Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to enrollment and agree to use adequate contraception during the study and for 3 months after the last study treatment. Men must be surgically sterile or agree to use adequate contraception during the study and for 3 months after the last study treatment; (11) Toxicities from prior therapies must have resolved to <=Grade 1 (surgical wounds must be fully healed, if applicable); (12) Patients must voluntarily participate, provide signed informed consent, demonstrate good compliance, and be able to follow the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Major surgery within 4 weeks prior to enrollment (excluding minor outpatient procedures such as vascular access placement); patients requiring surgical stabilization of bone lesions intended for irradiation; 2.Uncontrolled hypertension despite medical therapy (persistent systolic >=150 mmHg or diastolic >=100 mmHg); 3.Uncontrolled cardiac symptoms or disease, including: (1) NYHA Class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within the past 12 months; (4) Clinically significant supraventricular or ventricular arrhythmias requiring intervention; 4.Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [patients with stable replacement therapy may be eligible]). Patients with childhood asthma that has completely resolved without treatment in adulthood, or patients with vitiligo, may be included; patients requiring medical intervention with bronchodilators are excluded; 5.Known congenital or acquired immunodeficiency, including HIV infection, active hepatitis B (HBV DNA >=500 IU/mL), active hepatitis C (HCV antibody positive with HCV RNA above detection limit), or HBV/HCV coinfection; 6.Severe infection within 4 weeks before first dose (requiring IV antibiotics, antifungals, or antivirals), or unexplained fever >38.5°C during screening or before first dose; 7.Arterial or venous thromboembolic events within 6 months prior to enrollment, including cerebrovascular accident (TIA, hemorrhage, infarction), deep vein thrombosis, or pulmonary embolism; 8.Known allergy to any investigational drug component; 9.Pregnant or breastfeeding women, or patients of reproductive potential unwilling to use effective contraception; 10.History of significant neurological or psychiatric disorders, including epilepsy and dementia; 11.Uncontrolled or symptomatic active central nervous system (CNS) metastases, including clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive lesions; 12.Any other condition deemed unsuitable by the investigator, including but not limited to family or social circumstances that may compromise patient safety or compliance, or collection of study data/samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event (AE);Objective Response(OR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression (TTP);Progression-free survival (PFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactRutian Li
Nanjing Drum Tower Hospital
Outcome results
None listed