Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Intraluminal Injection of FOLactis in Patients With Advanced Solid Tumors Accompanied by Malignant Pleural and Peritoneal Effusion

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country40 target enrollmentMay 1, 2023

ConditionsSolid Tumor Immune Response Pleural Effusion, Malignant Peritoneal Effusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Solid Tumor
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment: 40
Locations: 1
Primary Endpoint: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical study is a single arm, prospective, single center clinical study on the safety, tolerability, and preliminary efficacy of a novel FOLactis in situ vaccine in the treatment of advanced solid tumors with malignant pleural and peritoneal effusion. The safety, tolerability and preliminary efficacy of intraluminal injection of FOLactis combined with systemic anti-tumor therapy will be evaluated.

Registry

clinicaltrials.gov

Start Date

May 1, 2023

End Date

May 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age range from 18 to 80 years old, both male and female;
•Eastern Cooperative Oncology Group Performance Status score 0-2 poinRecurrent or metastatic solid tumors confirmed by pathology (including but not limited to pancreatic cancer, colorectal cancer, lung cancer, liver cancer, cholangiocarcinoma, gastrointestinal stromal tumor, head and neck tumor, gastric cancer, bone and soft tissue sarcoma, neuroendocrine tumor, etc.);
•Malignant pleural/abdominal effusion confirmed by pathology;
•Expected survival time ≥ 12 weeks;
•The main organ function and bone marrow function are normal, meeting the following requirements:
•Hemoglobin ≥ 80 g/L (no blood transfusion within 14 days);
•Absolute neutrophil count ≥ 1.5 × 109/L, and white blood cell count ≥ 3 × 109/L;
•Platelet count ≥ 90 × 109/L;
•If there is no liver metastasis, total bilirubin\<1.5 × ULN; If there is liver metastasis or Gilbert syndrome in patients with high indirect bilirubinemia, total bilirubin\<3 × ULN;
•If there is no confirmed liver metastasis, AST and ALT\<2.5 × ULN; If there is confirmed liver metastasis, AST and ALT\<5 × ULN;

Exclusion Criteria

•Within 4 weeks prior to enrollment, major surgeries were performed (excluding outpatient minor surgeries such as placement of vascular pathways);
•Even after medication treatment, hypertension is still not well controlled (continuous increase in systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100mmHg);
•Suffering from uncontrollable clinical symptoms or diseases of the heart, including: (1) NYHA II and above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias who require clinical intervention;
•Having any history of active autoimmune diseases or autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy);
•The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other therapeutic hormones), and continues to use them within 2 weeks before enrollment;
•Has experienced severe allergic reactions to other monoclonal antibodies; Abnormal coagulation function (INR\>2.0, PT\>16s), with bleeding tendency or undergoing thrombolytic or anticoagulant treatment, allowing prophylactic use of low-dose aspirin and low molecular weight heparin;
•HIV positive; HCV positive; Uncontrolled active hepatitis B;
•Severe infection (such as requiring intravenous drip of antibiotics, antifungal or antiviral drugs) within 2 weeks before the first medication, or unexplained fever\>38.5 ℃ during screening/before the first medication;
•Arterial/venous thrombotic events that occurred within 6 months prior to enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
•Known to be allergic to any investigational drug;