cervical carcinoma
Conditions
Interventions
Test group:Within 28-56 days of the end of simultaneous radiotherapy treatment, 6 cycles of adjuvant treatment with karelizumab, 200 mg, d1, q3w, were received on top of the control regimen.
Control group:none
Sponsors
The Second Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
No minimum to 40 Years
Inclusion criteria
Inclusion criteria: 1) Patients with cervical cancer diagnosed by pathology; 2) 2018 FIGO clinical staging of stage IB3 to IVA (broadly locally advanced); 3) Expected survival >= 3 months; 4) ECOG score: 0 - 2; 5) One of the following clinical features is met. a. Age >= 40 years; b.Pathological type non-squamous carcinoma; c. Maximum local tumour diameter >= 4 cm; d.Positive pelvic lymph nodes or para-aortic lymph nodes (PET/CT); e.SCC antigen >= 4 ng/mL; f. Initial haemoglobin < 90 g/L; 6) Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrolment with negative results and be willing to use an appropriate method of contraception for the duration of the trial and for 8 weeks after the final administration of the test drug; 7) Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant and co-operated with follow-up visits.
Exclusion criteria
Exclusion criteria: 1) Patients involved in clinical studies of other drugs within 4 weeks prior to the start of study treatment; 2) Severe hepatic and renal insufficiency, unable to receive radiotherapy and immunotherapy; 3) Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody or anti-lymphocyte antigen 4 (CTLA-4) antibody; 4) Subjects with known prior hypersensitivity to large protein preparations/monoclonal antibodies, or known hypersensitivity to any of the components of the test drug; 5) Those with active autoimmune disease and receiving systemic therapy (e.g., corticosteroids or immunosuppressive drugs) within the past 2 years; 6) Persons who have received a live vaccination within 30 days prior to the first study drug treatment; 7) Other conditions that, in the judgement of the investigator, may affect the conduct of the clinical study and the determination of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to death or distant metastasis;Overall survival period;Overall relief rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactZhang Ni
The Second Hospital of Chongqing Medical University
Outcome results
None listed