| Eligibility |
Inclusion Criteria:
1. For patients with recurrent or metastatic cervical cancer after initial standard
treatment (including radical surgery or radical radiotherapy), the lesions are located
out of the field of previous radiotherapy, with no more than 5 recurrent or metastatic
foci, and the radiotherapy is feasible according to the evaluation of radiotherapy
physician; and at least 1 lesion (without previous radiotherapy) meets the target
lesion standard of RECIST 1.1;
2. Cervical adenocarcinoma, squamous cell carcinoma or adenosquamous cell carcinoma
confirmed by previous histology;
3. Surgical resection is not recommended for recurrent lesions, or patients choose not to
accept surgery voluntarily;
4. The researchers evaluated the suitability of radiotherapy
5. ECoG 0-1; life expectancy > 6 months;
6. Aged 18-70 years;
7. No serious allergic history;
8. Hemoglobin > 100 g / L, WBC > 3.5 * 10 ^ 9 / L, neutrophils > 1.5 * 10 ^ 9 / L,
platelets > 100 * 10 ^ 9 / L, Cr < 1.5 * normal upper limit, TB < 2.5 * normal upper
limit, AST and Al < 2.5 * normal upper limit, AKP < 2.5 * normal upper limit;
9. Ability to sign informed consent.
Exclusion Criteria:
1. Histologically, small cell (neuroendocrine) cervical cancer, mucinous adenocarcinoma,
carcinosarcoma and other pathological types were confirmed;
2. Primary malignant tumor with activity in other parts, except for the following:
Those who have been cured have no known active disease at least 5 years before the
first IP administration, and the potential risk of recurrence is low;
Fully treat non melanoma skin cancer or malignant nevus without disease signs;
Fully treated carcinoma in situ, no signs of disease.
3. The recurrent lesions have received chemotherapy, radiotherapy or other anti-tumor
treatment;
4. Bone metastasis;
5. Brain metastasis;
6. Pregnant or lactating patients;
7. In the past, there was abnormal thyroid function, and under the condition of drug
treatment, thyroid function could not be maintained in the normal range;
8. Diagnosis of immune deficiency or treatment with chronic systemic steroids (doses more
than 10 mg per day of prednisone equivalent) or any other form of immunosuppressive
therapy within 7 days before enrollment;
9. Patients with active autoimmune diseases need systemic treatment in the past 2 years;
10. A history of (noninfectious) pneumonia requiring steroids or current pneumonia;
11. There are active infections that need systematic treatment;
12. Known history of human immunodeficiency virus (HIV) infection;
13. Known history of hepatitis B or known active hepatitis C virus infection;
14. Known history of active tuberculosis (TB);
15. Uncontrolled comorbidities, including but not limited to: persistent or active
infection, symptomatic congestive heart failure, uncontrolled hypertension,
uncontrolled diabetes, uncontrolled arrhythmias, active interstitial lung disease
(ILD), severe chronic gastrointestinal disease with diarrhea, or may limit compliance
with study requirements, leading to AE Mental / social problems that significantly
increase or affect the ability of subjects to provide written informed consent;
16. 14 days before admission, the operation was too large and had not recovered;
17. Participate in other clinical trials at present or within 28 days before selection;
18. Any indications, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1
and anti-PD-L2 antibodies or therapeutic anti-cancer vaccines, were treated by
immunomediated therapy prior to the study;
19. Any synchronous chemotherapy, research drug, biological product, or hormone therapy
used to treat tumors. Hormone therapy can also be used to treat non tumor related
diseases (e.g., hormone replacement therapy);
20. Allogeneic tissue / solid organ transplantation was carried out.
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