Solid tumor
Conditions
Interventions
Experimental group:High-dose radiotherapy (HDRT): Select small lesions (the diameter of each individual lesion must be less than 3 cm
if there are multiple HDRT lesions, the total volume must be less than 100 cm3), with a single dose of 8 Gy, total dose of 24 Gy (3 times)
Low-dose radiotherapy (LDRT): Select large lesions (the maxim
the remaining unirradiated lesions can be selectively irradiated, but it is not mandatory), with a single dose of 2.0 Gy, total dose of 4 Gy (2 times)
Immunotherapy: Begin administering adalimumab imm
Sponsors
Donghai County People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Age >= 18 years old, no gender restrictions; (2) The enrolled patients must have advanced solid tumors with recurrence or metastasis; (3) They must have experienced disease progression after receiving standard first-line systemic treatment; (4) The Eastern Cooperative Oncology Group (ECOG) score is 0-3, and the expected survival period is > 3 months; (5) According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), there must be at least two measurable lesions; (6) No history of immune diseases; (7) Basic blood indicators are normal: white blood cell count >= 4×10^9/L; absolute neutrophil count >= 1.5×10^9/L; platelets >= 100×10^9/L; hemoglobin >= 90 g/L; (8) Basic renal function is normal: serum creatinine = 60 mL/min; (9) Basic liver function is normal: serum total bilirubin <= 1.5×ULN (if there is liver metastasis, serum total bilirubin should be <= 3.0×ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5×ULN (<= 5.0×ULN if there is liver metastasis); (10) For female patients, a negative urine pregnancy test must be conducted before the start of the study (not applicable to patients with bilateral oophorectomy and/or hysterectomy or postmenopausal patients); (11) Sign a written informed consent form and be able to comply with the protocol during the study.
Exclusion criteria
Exclusion criteria: (1) The patient has any active autoimmune disease or has a history of autoimmune disease (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; the patient has vitiligo; if asthma was completely relieved during childhood and no intervention is required after adulthood, it can be included; patients with asthma who require bronchodilators for medical intervention cannot be included) (2) Participated in any other interventional clinical trial within 30 days before screening; (3) Is currently using immunosuppressants or systemic hormones to achieve immunosuppression (dose > 10mg/day prednisone or other equivalent efficacy hormones), and is still using them within 2 weeks before enrollment; (4) Has poorly controlled concurrent diseases (such as heart failure, diabetes, hypertension, thyroid disease, mental illness, etc.); (5) Known to be infected with HIV virus or have active viral hepatitis or other infectious diseases; (6) Allergic to the drugs or their components used in this protocol; (7) >= 2 grade peripheral nerve disease or hearing loss according to the standards of Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0); (8) Pregnant (confirmed by blood or urine HCG test) or lactating women, or reproductive-aged subjects who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment; (9) The investigator deems it inappropriate for the subject to participate in this study; (10) Refuses to participate in this study or is unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival period;9-month survival rate;12-month survival rate;Objective response rate of non-radiotherapy lesions; | — |
Countries
China
Contacts
Public ContactYanlin Li
Donghai County People's Hospital
Outcome results
None listed