Advanced solid malignant tumors
Conditions
Interventions
Experimental group:1) Radiotherapy: Choose a primary or metastatic lesion that has not been irradiated before and has minimal impact on the surrounding normal tissues for radiation therapy, with a tot
after completing 6 cycles of sequential GM-CSF maintenance with Envafolimab, continue maintenance with Envafolimab monotherapy until disease progression.
Sponsors
Fuyang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years; 2) Recurrent or metastatic advanced solid malignant tumors, with a clear pathological diagnosis report or medical history, no clear standard treatment recommended by guidelines or intolerance to standard treatments and explicit refusal of standard treatment by the patient due to personal preference, and clear measurable metastatic lesions; 3) No occurrence of congestive heart failure, unstable angina, or unstable arrhythmias within the past 6 months; 4) ECOG PS (Eastern Cooperative Oncology Group Performance Status) score: 0-3; 5) Expected survival = 12 weeks; 6) No history of serious hematopoietic, heart, lung, liver, kidney dysfunction, or immune deficiency; 7) One week prior to enrollment, absolute T lymphocyte count = 0.5 times the lower limit of normal, neutrophils = 2.0×10^9/L; AST (aspartate aminotransferase) and ALT (alanine aminotransferase) = 3.0 times the upper limit of normal (for patients with liver cancer/metastatic liver cancer = 5.0 times), creatinine = 3.0 times the upper limit of normal; 8) Women of childbearing potential must agree to use effective contraception (such as an intrauterine device, contraceptives, or condoms) during the study period and for 6 months after the study ends; a negative serum pregnancy test within 72 hours before the first administration and must not be breastfeeding; men must agree to use effective contraception during the study period and for 6 months after the study ends. 9) Patients voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients with contraindications to resuming immunotherapy; 2) History of gastrointestinal perforation and/or fistula within 6 months before the first drug use; 3) Tumors significantly invading adjacent organs (major arteries or trachea) of esophageal lesions, leading to a higher risk of bleeding or fistula; 4) Subjects with past or concurrent other malignancies (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ); 5) Subjects with any active autoimmune diseases or a history of autoimmune diseases (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has completely resolved in childhood and requires no intervention in adulthood can be included; subjects requiring bronchodilators for medical intervention of asthma cannot be included); 6) Uncontrolled clinical symptoms or diseases of the heart, such as: (1) Heart failure above NYHA class 2 (2) Unstable angina (3) Myocardial infarction occurred within the past year (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 7) Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (for hepatitis B: HBsAg positive, and HBV DNA values higher than the upper limit of normal; for hepatitis C: HCV antibody positive, and HCV viral load values higher than the upper limit of normal); 8) Patients requiring immunosuppressant therapy for organ transplantation; 9) Serious infection (CTC AE > Grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, complications of infections requiring hospitalization, etc.; Baseline chest imaging suggests active pulmonary inflammation, symptoms and signs of infection existing within 2 weeks before the first use of the study drug or requiring treatment with oral or intravenous antibiotics, except for prophylactic use of antibiotics; 10) History of interstitial lung disease (except for radiation pneumonitis that has not been treated with steroids), history of non-infectious pneumonia; 11) Patients with active tuberculosis infection found by history or CT examination, or patients who had active tuberculosis infection within 1 year before enrollment, or patients who had active tuberculosis infection more than 1 year ago but were not properly treated; 12) Pregnant or breastfeeding women; patients of childbearing potential unwilling or unable to use effective contraception; 13) Known allergy to the study drug or its excipients; 14) Any other factor that the researcher considers unsuitable for entering the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival ;duration of response; | — |
Countries
China
Contacts
Public ContactGuangming Wang
Fuyang Cancer Hospital
Outcome results
None listed