Postoperative cervical cancer with high-risk factors
Conditions
Interventions
Test group:Concurrent chemoradiotherapy with cisplatin / carboplatin combined with Iparomlimab and Tuvonralimab injection
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged 18-70 years; ECOG physical status score 0-1; Estimated survival >= 6 months; 2.After radical hysterectomy for cervical cancer; 3.Postoperative imaging (enhanced ct/mri) confirmed that there was no distant metastasis and residual lesions after surgery, and pelvic anatomy was suitable for radiotherapy planning design; 4.Cervical cancer (squamous carcinoma, adenocarcinoma or adenosquamous carcinoma) was confirmed by histopathology, and postoperative pathology was accompanied by high-risk factors (at least 1 item was met): pelvic lymph node metastasis was positive, parametrial invasion was positive, vaginal resection margin was positive; 5.Blood routine: hemoglobin >= 9g/dl, neutrophil absolute value >= 1.5 × 10 ^ ? /l, platelet >= 100 × 10 ^ ? /l; liver function: total bilirubin = 60ml/min (Cockcroft Gault formula); 6.No serious cardiopulmonary disease (such as uncontrolled hypertension and heart failure); 7.They voluntarily signed informed consent, had good compliance, and received regular follow-up.
Exclusion criteria
Exclusion criteria: 1.Postoperative pathology suggested non cervical primary tumors (such as endometrial cancer metastasis); 2.Previous or combined with other malignant tumors (except malignant tumors cured for = 5 years); 3.Organ transplantation history or need long-term systemic immunosuppressant treatment (such as glucocorticoid > 10 mg/ day prednisone equivalent dose); 4.Received immunotherapy before operation (such as pd-1/pd-l1/ctla-4 inhibitors); 5.Previous abdominal or pelvic radiotherapy; 6.History of allergy to platinum drugs (cisplatin / carboplatin) or study drugs; 7.Autoimmune diseases and immune status: active autoimmune diseases need systemic treatment (allowing stable hypothyroid hormone replacement therapy, vitiligo, type I diabetes); Interstitial lung disease (except asymptomatic old pulmonary fibrosis) or uncontrolled pleural effusion / ascites (requiring drainage > 1 time / month); Primary or acquired immunodeficiency status (such as HIV infection, cd4+ T cells < 200/ µ L); History of uncontrolled autoimmune hepatitis, nephritis, pneumonia, etc; 8.Pregnant or lactating women, or women of childbearing age do not take effective contraceptive measures; 9.Mental illness or cognitive impairment can not cooperate with treatment; 10.Participate in other clinical trials within 4 weeks before enrollment; 11.The investigator considered that it was not suitable for enrollment (such as poor compliance, unable to tolerate concurrent chemoradiotherapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;3-year overall survival rate;Disease free survival based on PD-L1 stratification;5-year disease-free survival rate;5-year overall survival rate;3-year disease-free survival rate; | — |
Countries
China
Contacts
Public ContactYunyan Zhang
Harbin Medical University Cancer Hospital
Outcome results
None listed