Advanced malignancies
Conditions
Interventions
Photosensitizer Dose Group:The dose escalation part of LS-HB for injection (Part I) consisted of about 5 dose groups of photosensitizers, which were dose group 0 (0.05 mg/kg), dose group 1 (0.1 mg/kg)
Light dose group:The light dose escalation part (Part 2) includes 6 photosensitizer doses, which are 0.2 mg/kg, 0.6 mg/kg, 1.0 mg/kg, 1.5 mg/kg, 2.0 mg/kg, and 2.5 mg/kg. The dose escalation follows a
Sponsors
The First Affiliated Hospital of He'nan University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Agree to follow the trial treatment plan and visit plan, voluntarily enroll, and sign an informed consent form in writing; 2. On the day of signing the informed consent form, the age is 18 years old, regardless of gender; 3. Patients with recurrent and/or metastatic advanced malignant tumors confirmed by histology or cytology without standard treatment or with standard treatment failure or intolerance, including but not limited to obstructive esophageal cancer (including esophageal gastric junction cancer), NSCLC with tracheal or bronchial obstruction, head and neck cancer, etc; 4. Stooler dysphagia grade 2 or higher esophageal cancer (including esophageal gastric junction cancer) patients (only applicable to esophageal cancer [including esophageal gastric junction cancer] patients); 5. According to the judgment of researchers, there is at least one local tumor lesion suitable for photodynamic therapy, such as respiratory tumors with tracheal or bronchial obstruction and intraluminal or intraluminal+wall type tumors, or esophageal cancer (including esophageal and gastric junction cancer) patients who are not suitable for surgery, radiotherapy and chemotherapy, or elderly esophageal cancer (including esophageal and gastric junction cancer) patients, or esophageal obstruction patients with tumor recurrence after radiotherapy and chemotherapy or surgery; 6. Patients with asymptomatic brain metastases who have not had any central nervous system metastasis or have not received any treatment for brain metastases, or who have been clinically and imageologically stable for at least 4 weeks prior to screening, are required to avoid long-term use of corticosteroids for the latter two conditions; 7. Estimated survival time >=12 weeks; 8. The baseline Eastern Oncology Collaborative Group (ECOG) score (see Appendix 1) is 0 or 1; 9. The subjects have sufficient organ and bone marrow function to meet the following laboratory test: Criteria for bone marrow function: absolute neutrophil count (ANC) >=1.5 × 10^9/L (1500/mm3); Platelet count (PLT) >=100 × 10^9/L (1 × 10^5/mm3); Hemoglobin (HGB) >= 9.0 g/dL (whole blood transfusion or use of components such as white blood cells and platelets is not acceptable within 14 days prior to screening); Liver function: serum total bilirubin (T-Bil)= 60 mL/min (calculated using the Cockcroft Gault formula for Ccr, see Appendix 3); Coagulation function: international standardized ratio (INR) <= 1.5 times ULN, activated partial thromboplastin time (APTT) <= 1.5 times ULN; 10. The researchers determine that the patient must recover from any AE related to previous treatment (< level 2), except for the following situations: a. hair loss; b. Pigment deposition; c. The long-term toxicity caused by radiotherapy cannot be restored according to the judgment of the researchers; d. Level 2 and below neurotoxicity caused by platinum (CTCAE V5.0); 11. Men and women of childbearing age who have fertility are willing to take effective cont
Exclusion criteria
Exclusion criteria: 1. Individuals who are known to be allergic to the active ingredients or excipients of LS-HB for injection, or have a history of specific allergic reactions (asthma, rheumatism, eczema dermatitis) that the researcher deems unsuitable for treatment with the investigational drug; 2. Previously treated with photosensitizers; 3. Those who have used other photosensitive drugs (tetracyclic antibiotics, sulfonamides, phenothiazines, sulfonylurea hypoglycemic drugs, thiazide diuretics, and griseofulvin, etc.) within 28 days before the administration of the experimental drug; 4. Those who have received any experimental drug treatment or used experimental instruments within 28 days prior to the first administration of the experimental drug; 5. Within 28 days prior to the first administration of the investigational drug, any systemic anti-tumor therapy, including systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy (small molecule targeted drugs within 2 weeks prior to first administration), systemic immunomodulators (including but not limited to interferon, interleukin-2, and tumor necrosis factor), has been used; 6. Have received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor effect within 2 weeks before the first administration; 7. Received bevacizumab treatment within 6 weeks prior to initial administration; 8. Excluding in situ cervical cancer and non melanoma skin cancer that have received curative treatment and have been cured of another type of malignant tumor within the past 5 years; 9. Patients who have been confirmed by endoscopy or other examinations to have esophagotracheal fistula, esophageal/tracheal mediastinal fistula, bronchopleural fistula, damage to bronchial wall structure, or a risk of tumor invasion of surrounding large blood vessels (applicable to patients with esophageal cancer [including esophageal gastric junction cancer] and respiratory tumors); 10. Not suitable for endoscopic examination (applicable to patients with esophageal cancer (including esophageal gastric junction cancer) and respiratory tumors); 11. Patients with severe stenosis of the lumen caused by tracheal tumors (>75%, applicable to patients with respiratory tumors); 12. Patients with eye diseases who require ophthalmic light examination within 28 days after LS-HB administration; 13. Those who have undergone significant surgical treatment or significant traumatic injury within 28 days prior to the first administration of the investigational drug; 14. Pregnant or lactating women; 15. Any uncontrollable serious clinical research related issues (such as drug abuse, uncontrolled mental illness or cognitive impairment, uncontrolled pleural effusion and/or pericardial effusion or other serious heart and cerebrovascular diseases, uncontrolled complications, including active infections, arterial thrombosis and symptomatic pulmonary embolism, patients in a malignant fluid state); 16. A positive result for one or both of the Treponema pallidum antibodies or human immunodeficiency virus antibodies, or an active hepatitis B patient (defined as hepatitis B virus [HBV] DNA exceeding normal values, such as >= 1000 IU/mL), or an active hepatitis C patient (defined as hepatitis C virus [HCV] RNA exceeding normal values, such as >= 1000 IU/mL); 17. Patients with active, known or suspected autoimmune diseases, or with a history of autoimmune diseases, except for the following: vitiligo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phototoxicity Testing;Laboratory tests;Vital signs;12-lead ECG;Physical examination;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Stooler Dysphagia Grade;PK evaluation indicators; | — |
Countries
China
Contacts
Public ContactShegan Gao
The First Affiliated Hospital of He'nan University of Science and Technology
Outcome results
None listed