Cervical cancer
Conditions
Interventions
Experimental group:Iparomlimab/Tuvonralimab injection
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written ICF. 2. The age at enrollment was > =18 years old, = 3 months. 5. Pathologically confirmed HPV-associated cervical squamous, adenocarcinoma, or adenosquamous carcinoma. 6.FIGO 2018 stage III-IVA, TNM stage T3a-4a, N1 (positive LNM on CT/MRI, minimum transverse diameter >= 1cm, or 1 or more LNM on PET-CT, SUVmax >=2.5), M0; 7. At least one measurable tumor lesion according to RECIST v1.1 criteria. 8. Good function of major organs: Hematology (no blood component and cell growth factor support therapy within 7 days before starting study treatment) : (1) Absolute neutrophil count > 1.5 ×10^9/L (1500 /mm^3). (2) Platelet count > = 100 ×10^9/L (100,000/mm^3). (3) hemoglobin > = 90 g/L. Kidney: (1) Creatinine clearance rate (CrCl) calculated value > = 50 mL/min. * Cockcroft-Gault formula will be used to calculate CrCl (Cockcroft-Gault formula) CrCL (mL/min) = [(140 - age) * F] weight (kg)/(SCr (mg/dL) x 72) F=1 for male and F=0.85 for female. SCr = serum creatinine. (2) urinary protein = 50%. 9. Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 3 days before the first dose of medication (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test should be performed, and the result is negative). If a female subject of childbearing potential has sex with an unsterilized male partner, the subject must be using an acceptable method of contraception from the time of screening and must agree to continue using contraception for 120 days after the last dose of study drug. Discontinuation of contraception after this time point should be discussed with the investigator. 10. Participants were willing and able to comply with the scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Participants will be excluded if they meet any of the following: 1. Has other histological types of cervical cancer, such as neuroendocrine carcinoma or sarcoma. 2. Has evidence of metastatic disease (including lymph nodes above the first lumbar vertebra (L1) cephalad body, in the inguinal region) 3. Has undergone a previous hysterectomy (subtotal or cervical-sparing surgery allowed) 4. Has anatomy or tumor geometry or any other reason or contraindication that cannot be treated with intracavitary brachytherapy or a combination of intracavitary and interstitial brachytherapy 5. Has an intrauterine metallic device that precludes the safe performance of MRI 6. Has another active malignancy within 2 years prior to enrollment, except for malignancies that are considered cured and are unlikely to recur, such as adequately treated squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the breast 7. Has bilateral hydronephrosis, not adequately relieved by nephrostomy or ureteral stenting, as determined by the investigator 8. Has received prior therapy with an immune checkpoint inhibitor (e.g., anti–PD-1 antibody, anti–PD-L1 antibody, anti–CTLA-4 antibody) or any other agent targeting tumor immunologic pathways, such as antibodies directed against immune co-stimulatory molecules (e.g., ICOS, CD40, CD137, GITR, or OX40). 9. Has received systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or other immunosuppressive medication within 2 weeks prior to enrollment, except for the following conditions: a) Inhaled, ophthalmic, or topical corticosteroid therapy at doses 150 mmHg or diasto
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Progression-Free Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease Control Rate;Duration of Response;Progression-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactLingying Wu
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed