Cervical cancer
Conditions
Interventions
experimental group:Cardonilizumab combined with induction chemotherapy was followed by concurrent chemoradiotherapy for locally advanced cervical cancer
Sponsors
The First Hospital of Lanzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Subject is able to understand and voluntarily sign a written informed consent document. Informed consent must be signed prior to performing the specified study procedures required by the study. 2) Age >=18 years, female, on the day of signing the informed consent. 3) Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1. 4) Expected survival >=3 months. 5) Histologically or cytologically confirmed cervical cancer. a) The pathological type is squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma; b) Not receiving any anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy and immunotherapy). Note: Pelvic lymph node or para-aortic lymph node resection or biopsy for clinical staging purposes is permitted. c) FIGO 2018 stage III.A-IV.A, if diagnosis of stage III.C1, >=2 confirmed metastases are required. Diagnosis of lymph node metastasis can be confirmed by biopsy or imaging; Imaging to diagnose lymph node metastasis requires one of the following criteria: • MRI or CT shows positive lymph nodes (minimum transverse diameter >=10mm), note that the minimum transverse diameter needs to be >=15mm to be the target lesion. • 18F-FDG PET/CT showed positive lymph nodes (SUVmax>=2.5). 6) According to RECIST v1. 1 Criterion: At least one measurable tumor lesion. 7) All subjects must be willing to provide tumor tissue samples prior to randomization. 8) The results of laboratory tests during the screening period indicate that the subject has good organ function: a) Hematology (no use of any blood components and cell growth factor supportive therapy is allowed within 2 weeks prior to randomization): • Absolute neutrophil ANC > = 1.5×10^9/L; • International Normalized Ratio (INR) =100×10^9/L; • Hemoglobin > = 9.0 g/dL. b) Kidneys: • Creatinine = 50 mL/min; • Calculate CrCl using the Cockcroft-Gault formula CrCl (mL/min) = { (140-age) × body weight (kg) × 0.85/(serum creatinine (mg/dL) ×72). c) Liver: • Serum total bilirubin (TBil) <=1.5 × ULN; Subjects with evidence confirmed/suspected of Gilbert's disease, TBil < = 3×ULN; • AST and ALT < = 2.5×ULN. d) Coagulation function: blood plastin time (APTT) <=1.5 × ULN (if the subject is receiving anticoagulant therapy, the subject must be on a stable dose of anticoagulant and the coagulation parameters (PT/INR and APTT) are within the expected range of treatment with anticoagulants at screening). 9) Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. If a female subject of childbearing potential has sexual activity with a male partner who is not sterilized, the subject must be using an acceptable and effective method of contraception from screening and must agree to continue using these precautions until 120 days after the last dose of study drug and at least 180 days after chemoradiotherapy; Periodic abstinence, rhythm contraception is not an acceptable method of contraception. a) Females of childbearing potential are defined as women who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or non-menopausal (menopause is defined as menopause for at least 12 consecutive months without alternative medical reasons, and serum follicle-stimulating hormone levels are within the laboratory reference range for p
Exclusion criteria
Exclusion criteria: 1) Subjects with other pathological histological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc. 2) Evidence of distant metastases, including inguinal lymph node metastases and above the level of the superior border of the proximal L1 vertebral body Lymph node metastases. 3) Have undergone total hysterectomy (removal of the uterine body + cervix). Subtotal hysterectomy or keratotomy A history of cervix-sparing surgery such as surgery is permitted. 4) Unable to use brachytherapy due to anatomical abnormalities and other reasons, refusal to undergo brachytherapy. 5) MRI imaging is not possible for indwelling metal IUDs. 6) Other active malignant tumors within 2 years prior to randomization, except for locally curable tumors and manifestations Those who have been cured, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, and breast Carcinoma in situ. 7) Presence of clinically significant bilateral hydronephrosis, which cannot be underperformed by nephrostomy as judged by the investigator Ureteral stenting remission. 8) Previous treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.) or immune costimulatory factors (e.g., antibodies against ICOS, CD40, CD137, GITR, OX40 targets, etc.) that targets the tumor immune mechanism. 9) Subjects who require systemic treatment with glucocorticoids (> 10 mg/day prednisone or equivalent doses of glucocorticoids) or other immunosuppressive drugs within 2 weeks prior to randomization; Exceptions are made for the following: a) Inhaled, ophthalmic, or topical dose 150 mmHg, diastolic blood pressure > 100 mmHg) that is not controlled by adequate antihypertensive medication, or history of hypertensive crisis, hy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Time to Response;Disease-free Survival;Disease Control Rate;During of Response; | — |
Countries
China
Contacts
Public ContactWang Lina
The First Hospital of Lanzhou University
Outcome results
None listed