| Eligibility |
Inclusion Criteria:
1. Age=18;
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
3. Have recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma, or
adenocarcinoma of the cervix;
4. Oligometastases and Oligo-recurrence( number of metastatic organs =3, and the total
number of metastases =5), with indications for radiotherapy, and which has not been
treated with systemic chemotherapy;
5. At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors
(RECIST) guideline 1.1;
6. Anticipative survival period of 3 months or more;
7. Have adequate organ function as indicated by the following laboratory values: (1)
Hematological:Absolute neutrophil count
(ANC)=1.5×109/L;Platelets(PLT)=90×109/L;Hemoglobin(Hb)=90 g/L; (2) Hepatic:Serum total
bilirubin (TBIL)=2.5×ULN;ALT ? AST=2×ULN; (3) Renal:BUN ? Cr = 1.5×ULN;
8. Cardiac ultrasound:LVEF=50%;
9. A WOCBP who has a positive blood pregnancy test within 72 hours prior to
randomization(Postmenopausal women who have had amenorrhea for at least 12 months are
considered infertile, and women who are known to have received Tubal ligation do not
require a pregnancy test);
10. For subjects who were not menopausal or had not undergone surgical sterilization,
consent to abstinence or use of an effective contraceptive method was given during
treatment and at least 5 months after the last administration of the drug during study
treatment;
11. Volunteer to join the study, sign informed consent, have good compliance and willing
to cooperate with the follow-up.
Exclusion Criteria:
1. Patients who have received prior therapy with an anti-EGFR an anti-PD-1, anti-PD-L1
agent; Has a contraindication or hypersensitivity to Macromolecular protein
preparationsany and component of Nimotuzumab and Tislelizumab
2. Other malignancies diagnosed within 5 years before the first dose, excluding basal
cell carcinoma of the skin, squamous cell carcinoma of the skin and papillary thyroid
carcinoma;
3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy,
prior therapy with other targeted therapy and any anti-vascular endothelial growth
factor (VEGF) drug. Other anti-tumor treatments not included in this trial protocol;
4. Patients who are pregnant or nursing. Patients of childbearing potential must agree to
use contraceptive measures during study therapy and for at least five months after
completion of this study.
5. Patients with recto-vaginal fistula,vesicovaginal fistula, uncontrolled vaginal
bleeding and no underlying process leading to fistula;
6. Major surgical procedure unrelated to cervical cancer,and has not recovered adequately
from toxicity and/or complications from surgery within 4 weeks before enrollment;
7. Has a known history of human immunodeficiency virus (HIV) infection,or has other
acquired, congenital immunodeficiency disease, or has a history of organ
transplantation;
8. Uncontrolled hypertension , cardiac arrhythmia and pulmonary disease.Has a known
history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg]reactive) or
known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected)
infection.
9. Has known active Central Nervous System (CNS)metastases and/or carcinomatous
meningitis. Participants with known brain metastases may participate provided that the
brain metastases have been previously treated (except with chemotherapy) and are
radiographically stable more than 2 weeks. Known brain metastases are considered
active, if any of the following criteria are: There were measurable lesions outside
the central nervous system, no metastases to meninges, midbrain, pons, cerebellum,
medulla oblongata or spinal cord, no previous history of intracranial hemorrhage, and
steroid therapy was discontinued 14 days before the first dose of study drug.
10. Patients with clinical signs or fluids of pleural effusion, ascites, or pericardial
effusion requiring drainage (required or not significantly increased within 3 days of
discontinuation of drainage) may be eligible;
11. Any previous arterial thrombosis, thrombosis, or ischaemia, such as myocardial
infarction, unstable angina, cerebrovascular accident, etc., occurred in the previous
6 months.A history of deep venous thrombosis or any other serious thromboembolism
(implanted venous port or catheter-derived thrombosis, superficial venous thrombosis,
or thromboembolic stability after conventional therapy were not considered as serious"
thromboembolism" during the first 3 months of enrollment";
12. Cancer thrombus in the portal vein involves both the main and right branches of the
portal vein, or both the main and the superior mesenteric and inferior vena cava
thrombus; the superior vena cava thrombus and the superior vena cava syndrome;
13. Tumour involvement of vital peripheral organs or vessels (such as the great vessels of
the mediastinum, superior vena cava, inferior vena cava, abdominal aorta, iliac
vessels, trachea, esophagus, etc.) or risk of esophageal-tracheal or esophageal
pleural fistula;
14. History of interstitial pneumonia, pharmacologic pneumonia, radiation pneumonia,
idiopathic pneumonia, or active pneumonia;
15. Severe infection in active state or under clinical control.Severe infections occurred
within 4 weeks before the first dose, including but not limited to hospitalization for
infection, bacteremia, or complications of severe pneumonia.
16. Inability to perform internal exposure therapy by the Investigator's assessment;
17. Patients who do not understand the requirements of the trial or may not comply with
them.
18. Participants were identified as having any medical, psychiatric, or other condition or
condition that may adversely affect their safety or the reliability of study data.
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