| Eligibility |
Inclusion Criteria:
1. The subject must sign the written informed consent form (ICF) voluntarily.
2. Aged = 18years, female.
3. Histologically or cytologically confirmed cervical cancer, ? recurrent or metastatic
(FIGO IVB) cervical cancer, not amenable to curative surgery or concurrent
chemoradiotherapy, no prior systemic therapy for persistent, recurrent or metastatic
disease, or ? subjects have demonstrated radiologically confirmed disease progression
during or after last treatment, subjects will have no more than 2 lines of systemic
therapy in the recurrence or metastatic stages. neoadjuvant chemotherapy, adjuvant
chemotherapy, or Chemotherapy of non-recurrent or metastatic stage
chemoradiotherapy,will not be counted as a treatment line number.
4. The histological types include squamous cell carcinoma, adenocarcinoma, or
adenosquamous cell carcinoma.
5. At least 1 measurable lesion per RECIST v1.1, which is applicable for repeated
accurate measurement.
6. Life expectancy> 12 weeks.
7. Adequate organ function.
8. Female patients with fertility must have a urine or serum pregnancy test within 3 days
before the first medication (if the urine pregnancy test result cannot be confirmed as
negative, a serum pregnancy test is required, based on the serum pregnancy result),
and the result is negative. If a fertile female patient has sex with an unsterilized
male partner, the patient must use an acceptable contraceptive method since screening
and must consent to continued use of the contraceptive method for 120 days after the
last administration of the study drug; Whether to stop contraception after this time
point should be discussed with the investigator
9. Subjects must be willing and able to comply with the scheduled visits, treatment
regimens, laboratory tests, and other requirements in the study.
Exclusion Criteria:
1. Subjects had clinically significant hydronephrosis that could not be relieved by
nephrostomy or urethral stenting, as determined by the investigator.
2. Other active malignancies within 2 years prior to the first administration. Subjects
with locally curable tumors that appear to be cured, such as basal cell carcinoma of
the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or
carcinoma in situ of the breast, were not excluded.
3. Have received other study drugs or study devices within 4 weeks prior to the first
administration.
4. Concurrent enrollment in another clinical study, unless it is an observational,
non-interventional clinical study or a follow-up period of an interventional study.
(It was defined as more than 4 weeks between the first administration of the drug in
the study and the last administration of the drug in the previous clinical study or
more than 5 half-lives of the drug in the study)
5. An active infection requiring systemic therapy.
6. Subjects with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA
exceeding 1000 IU/ mL or active hepatitis C virus (HCV) should be excluded. Subjects
with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA <1000 IU/ mL),
and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are
eligible only if the HCV RNA test results are negative.
7. Known history of active tuberculosis (TB),In patients suspected of having active
tuberculosis, chest x-rays, sputum, and clinical signs and symptoms should be examined
for exclusion.
8. Receipt of live or attenuated vaccination within 30 days prior to the first
administration, or plan to receive live or attenuated vaccine during the study.
9. There are any of the following cardiovascular and cerebrovascular diseases or risk
factors for cardiovascular and cerebrovascular diseases:
Myocardial infarction, unstable angina pectoris, pulmonary embolism, acute/persistent
myocardial ischemia, cerebrovascular accident, transient ischemic attack, or other
arteriovenous thrombosis, embolism, or ischemic events that are clinically significant
or require pharmacological intervention occurred within 6 months prior to initial
administration.
Symptomatic congestive heart failure (classified as 3 or 4 according to the New York
Heart Association functional classification) occurring within 6 months before the
first administration.
Unstable arrhythmias or degree II/III atrioventricular blocks requiring
pharmacological intervention occurred within 6 months prior to initial administration.
10. Known history of serious hypersensitivity reaction to other monoclonal antibodies.
11. Pregnant or lactating women.
12. Any condition that the investigator believes may result in a risk of receiving the
study drug or combination therapy, or that would interfere with the evaluation of the
study drug or with patient safety or analysis of the study results.
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