advanced/relapsed endometrial cancer
Conditions
Interventions
Experimental group:1.Vediximab 2.5mg/kg intravenously in 21-day cycle
2.Carboplatin AUC=5 (maximum total dose not exceeding 1000 mg) intravenously in 21-day cycle
3.Triprolizumab 240 mg intravenously
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, signed an informed consent form, and had good compliance; 2. Endometrial cancer confirmed by histology, of any histopathological type; 3. Newly diagnosed advanced/recurrent endometrial cancer, who has not received first-line platinum based chemotherapy in the past; III-IVA stage requires measurable lesions according to RECIST 1.1 criteria, while IVB stage or recurrent patients have measurable/unmeasurable lesions; Note: If the disease recurs at least 6 months after the last chemotherapy, the neoadjuvant/adjuvant platinum based chemotherapy regimen is not included in the line count on the basis of curative surgery. If recurrence occurs= 1.5 × 10^9, platelet count >= 100 × 10^9, hemoglobin >= 90g/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<2.5 × upper limit of normal (UNL), total bilirubin<1.5 × UNL, serum creatinine<1.5 × UNL; 9. Subjects with potential fertility are required to use at least one medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period and within 180 days after the end of the study treatment; And the serum/urine HCG test must be negative before the first medication; And it must be non lactating.
Exclusion criteria
Exclusion criteria: 1. Histopathology contains sarcoma components (including leiomyosarcoma, endometrial stromal sarcoma, etc.)Cancer sarcoma can be included in this study; 2. Individuals who are known to have allergies to any of the drugs in the study; 3. Previous use of PD-1/PD-L1 monoclonal antibody or CTLA-4 monoclonal antibody; 4. Study active autoimmune diseases that require systematic treatment within 2 years before the start of treatment, or autoimmune diseases that the researcher determines may recur or plan treatment. Excluding: skin diseases that do not require systematic treatment (such as vitiligo, hair loss, psoriasis, or eczema); Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy; Childhood asthma has been completely relieved and no intervention is needed in adulthood; Researchers determine that the disease will not recur in the absence of external triggering factors; 5. Subjects who require systemic treatment with glucocorticoids (>10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days prior to the first administration. Except for the following: If there is no active autoimmune disease, inhaled, ophthalmic, or topical corticosteroids or other corticosteroids at doses not exceeding 10 mg/day of prednisone or equivalent are allowed for treatment; 6. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease; 7. Have received anti-tumor treatment (excluding endocrine therapy) within 28 days before the first use of the investigational drug; Not fully recovered from toxicity and/or complications caused by anti-tumor therapy, i.e. = 450 ms for males and >= 470 ms for females) (QTc interval calculated using the Fridericia formula); New York Heart Association (NYHA) functional class>II or left ventricular ejection fraction (LVEF)=500 IU/ml or 1000 copies/ml; HCV antibody positive and HCV copy number>upper limit of normal value); 13. Known to have another malignant tumor (other than endometrial cancer), which is currently in progress, or has received effective anti-tumor treatment in the past three years (various cancers in situ [such as breast cancer, bladder cancer, cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma have received potential curative treatment); 14. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 15. HIV positive; 16. Symptomatic brain metastases (confirmed or suspected); 17. The researchers believe that
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;Overall survival,OS;Disease control rate,DCR;During of response,DOR; | — |
Countries
China
Contacts
Public ContactLan Chunyan
Sun Yat-sen University Cancer Center
Outcome results
None listed