advanced solid tumors
Conditions
Interventions
intervention group:Ivosidenib combined with Nab-paclitaxel sequentially followed by spatially fractionated radiotherapy
Sponsors
Department of Oncology, Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 to 75 years inclusive. 2. Voluntarily sign a written informed consent form. 3. Histologically confirmed patients with advanced cancer in the post-line setting, as demonstrated by enhanced CT, cranial MRI, abdominal ultrasound, or PET-CT. 4. Failed after three or more lines of standard treatment, with an expected lifespan greater than 3 months. 5. Have at least one measurable tumor lesion according to RECIST 1.1. 6. Have an ECOG score of 0 or 1. 7. Have an expected survival duration of >=3 months. 8. Have been off radiotherapy, chemotherapy, hormone therapy, and molecular targeted therapy for more than 8 weeks, with all treatment-related adverse events resolved to baseline. 9. Have good major organ function: a) Hematology (without any blood component or cytokine growth factor support therapy within 7 days before starting the study treatment): i. Absolute neutrophil count (ANC) >= 1.5 × 10^9/L (1,500/mm³). ii. Platelet count >= 100 × 10^9/L (100,000/mm³). iii. Hemoglobin >= 90 g/L. b) Renal: i. Calculated creatinine clearance (CrCl) >= 50 mL/min using the Cockcroft-Gault formula. * CrCl (mL/min) = [(140 - age) × weight (kg) × F] / (SCr (mg/dL) × 72), where F=1 for males and F=0.85 for females; SCr = serum creatinine. ii. Urine protein < 2+ or 24-hour urine protein < 1.0 g. c) Liver: i. Total bilirubin (TBil) <= 1.5 × ULN. ii. AST and ALT <= 2.5 × ULN. iii. For subjects with liver metastases, TBil <= 3 × ULN; ALT and AST <= 5 × ULN. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 × ULN. 10. Female subjects of reproductive potential must have a negative serum pregnancy test within 3 days before the first dose. If a female subject of reproductive potential engages in sexual activity with a non-sterilized male partner, she must use an acceptable method of contraception starting from screening and must agree to continue using it for 6 months after the last dose of the study drug; the decision to discontinue contraception after this point should be discussed with the investigator. 11. Subjects are willing and able to comply with the scheduled visits, treatment regimen, laboratory tests, and other study requirements.
Exclusion criteria
Exclusion criteria: 1. Participation in treatment with experimental drugs or use of experimental devices within 4 weeks prior to the first administration of Evocimab. 2. History of other active malignancies within 3 years before enrollment, except for locally curable malignancies (demonstrated as cured) such as basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the endometrium, cervix, or breast. 3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study (defined as more than 4 weeks or more than 5 half-lives of the study drug from the last dose of the previous clinical study, whichever is longer). 4. Active autoimmune diseases requiring systemic treatment within 2 years before the start of study treatment, or autoimmune diseases that the investigator judges may recur or plan to treat; exceptions include: dermatological conditions not requiring systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; well-controlled Type 1 diabetes; childhood asthma that has fully resolved and requires no intervention in adulthood; and diseases judged by the investigator as unlikely to recur without external triggers. 5. Presence of active or clinically significant inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea). 6. Subjects requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days after starting study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalent are allowed in the absence of active autoimmune disease. Subjects may use local, ocular, intra-articular, intranasal, and inhaled corticosteroids (with minimal systemic absorption). Physiological replacement doses of systemic corticosteroids are allowed, even if >10 mg/day prednisone equivalent. Short-term use of corticosteroids for prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reactions due to contact allergens) is permitted. 7. Sarcoma patients who have previously received anti-angiogenic inhibitors (such as bevacizumab, anlotinib, pazopanib, regorafenib, etc.), and melanoma patients with BRAF V600E mutations excluding the use of targeted therapies (dabrafenib + trametinib, vemurafenib + cobimetinib, selumetinib). 8. Known history of positive testing for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). 9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 10. Known interstitial lung disease or history of interstitial lung disease. 11. Subjects with necrotic lesions detected within 4 weeks before enrollment, and the investigator judges there to be a risk of significant bleeding. 12. Severe infections occurring within 4 weeks before the first dose, including but not limited to those with complications requiring hospitalization, sepsis, or severe pneumonia. 13. Known active tuberculosis (TB). Subjects suspected of having active TB require chest X-ray, sputum examination, and exclusion based on clinical symptoms and signs. 14. Untreated chronic hepatitis B patients or chronic hepatitis B virus (HBV) carriers with HBV DNA >1000 IU/mL,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Ratel, DCR;Duration of Overall Response,DOR;Time to Remission, TTR;Progression-Free-Survival, PFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactLin Sheng
Department of Oncology, Affiliated Hospital of Southwest Medical University
Outcome results
None listed