For patients with EGFR-positive malignant tumors and oligometastases whose primary lesion has been radically treated and is well-controlled.
Conditions
Interventions
Trial group:Becotatug vedotin plus SBRT and investigator's choice of treatment regimen
Control group:SBRT plus investigator's choice of treatment regimen
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years (inclusive), male or female; 2. Patients with histologically or cytologically confirmed recurrent or metastatic solid tumors who are not amenable to curative surgery; 3. Oligometastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory). The total number of metastatic lesions must be = 6 months.
Exclusion criteria
Exclusion criteria: 1. History of severe hypersensitivity to any component of monoclonal antibodies; 2. The investigator's choice of systemic therapy regimen contains taxane-based (or other microtubule inhibitors) chemotherapy; 3. Severe infection within 4 weeks prior to the start of study treatment; or active infection of CTCAE Grade >= 2 requiring systemic antibiotic treatment within 2 weeks prior to the first dose; 4. Received anti-tumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other investigational drugs within 4 weeks prior to the first dose of study drug or investigator's choice of systemic therapy and SBRT; Exceptions: (1) The interval between the last dose of oral fluorouracil or small molecule targeted drugs and the first dose of study treatment is > 2 weeks or 5 half-lives (whichever is shorter); (2) The interval between the last dose of Traditional Chinese Medicine (TCM) with anti-tumor indications and the first dose of study treatment is > 2 weeks; (3) The interval between the completion of prior radioactive seed implantation and the first dose of study treatment is > 4 weeks or 5 half-lives of the seeds (whichever is shorter); the interval between the completion of Tumor Treating Fields and the first dose of study treatment is = II coronary heart disease, arrhythmia (including QTc interval prolongation > 450 ms for males, > 470 ms for females), or cardiac insufficiency; 10. Patients with brain metastases requiring surgical decompression; 11. Patients with malignant effusions; 12. Patients concomitant other malignancies; 13. Dementia or seizures; 14. Comorbidities requiring chronic use of immunosuppressive medication, or systemic or local corticosteroids at immunosuppressive doses, or receipt of high-dose corticosteroids within 4 weeks prior to enrollment; 15. Active pulmonary tuberculosis (TB), currently receiving anti-TB treatment, or received anti-TB treatment within 1 year prior to screening; 16. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo or childhood asthma that has completely resolved without need for intervention in adulthood are eligible; patients with asthma requiring bronchodilators for medical intervention are excluded; 17. HIV positive; HBsAg positive with detectable HBV DNA (quantitative detection >= 1000 cps/ml); positive blood screening for chronic Hepatitis C (HCV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Overall Response Rate (ORR);Health related quality of Life;Druation of response (DoR);Overall Survival (OS);Safety indicators; | — |
Countries
China
Contacts
Public ContactChen Mingyuan
Fifth Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed