Locally advanced cervical cancer
Conditions
Interventions
Group of Iparomlimab and Tuvonralimab:None
Sponsors
The Second Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 70 years old (calculated as of the date of informed consent signature), and those who voluntarily sign the informed consent form; 2.Histologically confirmed cervical carcinoma (pathological types include squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma), with available pathological reports for documentation; 3.FIGO 2018 stage IB3, IIA2, stage IIB with tumor diameter >=4 cm, and stage IIIC1 cervical cancer; 4.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2 and tolerable to chemotherapy; 5.No prior history of immunotherapy for malignant tumors; 6.Capable of understanding the study requirements and having signed the written informed consent form voluntarily;
Exclusion criteria
Exclusion criteria: 1.Patients with concomitant uncontrolled other malignancies; 2.Any disease requiring systemic treatment with corticosteroids (prednisone or equivalent at a daily dose >10 mg) or other immunosuppressive drugs within 14 days prior to enrollment. Topical replacement corticosteroids, short-term (<=7 days) prescribed corticosteroids for prophylaxis or non-autoimmune disease treatment with prednisone or equivalent daily dose<=10 mg are permitted. Subjects with active autoimmune diseases or a medical history of autoimmune disorders are excluded; 3.History of active autoimmune diseases or autoimmune diseases prone to relapse. Patients with well-controlled type 1 diabetes mellitus, hypothyroidism managed solely with hormone replacement therapy, well-controlled celiac disease, skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis or alopecia), or diseases unlikely to relapse without exogenous triggers are eligible for enrollment; 4.History of interstitial lung disease, non-infectious pneumonia, or poorly controlled pulmonary disorders (including pulmonary fibrosis, acute lung disease, etc.); 5.Subjects with active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] at screening plus HBV-DNA level exceeding the upper limit of normal (ULN) of the local laboratory at the study site) or active hepatitis C (defined as positive anti-HCV antibody at screening together with detectable HCV-RNA); 6.Confirmed human immunodeficiency virus (HIV) infection (positive anti-HIV antibody documented); 7.Administration of any live vaccine within 30 days prior to the first study drug administration, including but not limited to mumps, rubella, measles, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guérin (BCG) and typhoid vaccines. Inactivated vaccines are permitted; 8.Uncontrolled clinical cardiac signs or cardiac diseases; 9.Subjects with known hypersensitivity to any study drugs specified in this protocol; 10.Subjects with any ongoing or historical disease, ongoing treatment or laboratory abnormality that, in the Investigator’s judgment, may confound study results, interfere with full participation in the trial, or compromise the subject’s best interests to enroll in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate;Safty;Proportion of patients receiving postoperative adjuvant therapy;Pathological Complete Response Rate,pCR; | — |
Countries
China
Contacts
Public ContactLiying Zhang
The Second Affiliated Hospital of Guangxi Medical University
Outcome results
None listed