Cervical cancer
Conditions
Interventions
Experimental Group:QL1706
Sponsors
Tianjin Cancer Hospital Airport Hospita
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects were able to understand and voluntarily signed written informed consent. Informed consent forms must be signed prior to performing the specified study procedures required for the study. 2. Female >=18 years old on the date of signing the informed consent form. 3. Eastern Cooperative Oncology (ECOG) performance status of 0 or 1. 4. The expected survival time was >=6 months. 5. Histologically or cytologically confirmed cervical cancer. (1) The pathological type was squamous cell carcinoma; (2) without any anti-tumor treatment (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy and immunotherapy). Note: Resection or biopsy of pelvic or para-aortic lymph nodes for clinical staging purposes was permitted. (3) FIGO2018 stage ?A-?A, if stage ?C1 is diagnosed, more than =2 confirmed metastatic lymph nodes are required. The diagnosis of lymph node metastasis could be confirmed by biopsy or imaging. Imaging diagnosis of lymph node metastasis required meeting any of the following criteria: 1) If MRI or CT showed positive lymph nodes (minimum transverse diameter >=10mm), it should be noted that the minimum transverse diameter of lymph nodes should be >=15mm to be used as target lesions. 2) 18F-FDG PET/CT showed positive lymph nodes (SUVmax>=2.5) 6. At least one measurable tumor lesion according to RECIST v1.1 criteria. 7. Good organ function: (1) 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 /mm3); 2) platelet count >= 100 × 10^9/L (100,000/mm3); 3) hemoglobin >= 90 g/L. (2) 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) * 0.85} weight (kg)/(serum creatinine. (mg/dL) x 72) 2) urinary protein = 28 g/L (4) Coagulation function: 1) International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 50%. 8. 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 contraceptive method from the time of screening and must agree to continue using the method for 120 days after the last dose of the study drug. Discontinuation of contraception after this time point should be discussed with the investigator. Periodic abstinence and safe period contraception are not acceptable methods of contraception. 9. 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: 1. Subjects with other histopathological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc. 2. Evidence of distant metastasis, including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 vertebral body in the proximal cephalic region. 3. Prior hysterectomy (removal of corpus uteri and cervix). A history of cervical-sparing surgery such as subtotal hysterectomy or cornectomy was allowed. 4. Refusing to accept brachytherapy because of anatomical abnormalities or other reasons. 5. Magnetic resonance imaging cannot be performed with an indwelling metallic IUD. 6. Patients with other active malignant tumors within 2 years before enrollment, except those with locally curable tumors and shown to be cured, such as skin squamous cell carcinoma, skin basal cell carcinoma, superficial bladder cancer, and breast cancer in situ. 7. Presence of clinically significant bilateral hydronephrosis that, in the judgment of the investigator, could not be relieved by nephrostomy or ureteral stenting. 8. Previous treatment with immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.) or anti-immune costimulation factors (such as antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.) and other mechanisms of tumor immune action. 9. Subjects requiring systemic treatment with glucocorticoids (> 10 mg/ day prednisone or equivalent glucocorticoid) or other immunosuppressive drugs within 2 weeks before enrollment; Except for: (1)Inhaled, ophthalmic, or topical treatment with prednisone at a dose of 150mmHg and diastolic blood pressure >100 mmHg) with adequate antihypertensive drug therapy, or a history of hypertensive crisis or h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Safety analysis;Progression-free survival, PFS;3-year progression free survival (PFS) rate;Overall survival, OS;Duration of Response, DoR;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactChen Zhongjie; Xu Liming
Tianjin Cancer Hospital Airport Hospita
Outcome results
None listed