Late stage chest tumor
Conditions
Interventions
Experimental group:Recombinant human endostatin combined with lattice radiotherapy
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with tumors larger than 5 cm in maximum diameter who require palliative radiotherapy to alleviate symptoms. 2. Patients with advanced thoracic tumors confirmed by histology or cytology who are not suitable for surgery, conventional radiotherapy, or other treatments. (Meeting the following definitions: (1) Advanced thoracic malignancy confirmed by histology or cytology, not suitable for radical surgery. (2) Meeting any one of the following criteria to be enrolled: 1) Assessed as unresectable due to tumor location/size or relationship with critical structures; 2) Not suitable for or refusing standard platinum-based chemotherapy due to organ dysfunction, poor performance status, or other contraindications; 3) Previously received >=1 line of systemic therapy (chemotherapy, immunotherapy, or targeted therapy, etc.) with imaging-confirmed progression (RECIST 1.1) or permanently stopped treatment due to >= grade 3 toxicity, and MDT assessment indicates that continued standard treatment is no longer appropriate; 4) History of thoracic radiotherapy or other reasons making conventional fractionated external radiotherapy/concurrent chemoradiotherapy unsuitable; 5) Assessed by MDT that the risks of conventional treatment outweigh the benefits.) (3) At least one measurable lesion according to RECIST 1.1 criteria, with maximum lesion diameter >=5 cm, suitable for lattice radiotherapy. (4) ECOG performance status score of 0-2. (5) Age >=18 years, any gender. (6) Expected survival >=3 months. (7) Have good organ function and meet the following conditions: 1) Hematology: white blood cell count >= 3.0 × 10^9/L; absolute neutrophil count >= 1.5 × 10^9/L; hemoglobin >= 90 g/L; platelets >= 100 × 10^9/L 2) Liver function: total bilirubin = 60 mL/min (calculated by Cockcroft-Gault formula) 5) Cardiac function: left ventricular ejection fraction >= 50% (8) Women of childbearing potential must have a negative blood pregnancy test within 3 days before the first dose; women of childbearing potential and male patients agree to use effective contraception during the study and for 180 days after the last dose. (9) Patients fully understand the study, voluntarily participate, comply well, can cooperate to complete observation and follow-up, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled brain metastases or meningeal metastases (patients who are asymptomatic or whose symptoms have been stable for >=4 weeks after treatment may be included); 2. Cardiovascular diseases: myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months; NYHA class III-IV heart failure; uncontrolled arrhythmia; uncontrolled hypertension (systolic BP >=160mmHg or diastolic BP >=100mmHg); 3. Clinically significant bleeding events such as pulmonary hemorrhage (>2.5ml) or gastrointestinal bleeding within 3 months, or presence of active bleeding; 4. Coagulation disorders with significant bleeding tendency, or currently receiving full-dose anticoagulation therapy; 5. Major surgery within 4 weeks or presence of unhealed wounds, ulcers, or fractures; 6. Active infection requiring systemic anti-infective treatment; 7. Hepatitis B virus infection (HBsAg positive and HBV-DNA >=2000 IU/mL or 1×10^4 copies/mL); hepatitis C virus infection (HCV antibody positive and HCV-RNA above the lower limit of detection); HIV infection; 8. Uncontrolled pleural effusion, ascites, or pericardial effusion (patients with small effusions not requiring intervention may be included); 9. Other malignancies within the past 5 years (except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other tumors judged to have a low risk of recurrence after treatment); 10. Known allergy to recombinant human endostatin or any excipient in the formulation; 11. History of organ transplantation (including allogeneic bone marrow transplantation); 12. Psychiatric illness or disorders with poor compliance, unable to accurately describe adverse reactions; 13. Pregnant or breastfeeding women; 14. Other conditions deemed unsuitable for participation in clinical research by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. 3-6 months of Objective Response Rate (ORR) in the wild;Overall Survival (OS);Progression-Free Survival,PFS;Local Control Rate,LCR; | — |
Countries
China
Contacts
Public ContactYin Hang
Harbin Medical University Cancer Hospital
Outcome results
None listed