| Eligibility |
Inclusion Criteria:
- =18 years;
- ECOG 0-1
- Life expectancy of at least 3 months;
- Histologically or pathologically confirmed epithelial ovarian cancer (EOC), fallopian
tube cancer, primary peritoneal cancer; Ovarian cancer patients with drug-resistant
recurrence after platinum-based chemotherapy;
- At least one measurable objective tumor lesion by spiral CT examination, the maximum
diameter = 1cm(according to RECIST 1.1);
- Satisfactory main organ function,laboratory test must meet the following criteria:
hemoglobin (HGB) =90g/L, neutrophil count(ANC) =1.5×109/L, platelet count(PLT)
=80×109/L, Serum creatinine(CR)=1.5 upper normal limitation (UNL),total bilirubin
(TBil) =1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) =2.5 UNL (For patients with liver metastasis, the
AST/ALT must be =5.0 UNL), Activated partial thromboplastin time (APTT), international
normalized ratio (INR), prothrombin time (PT) = 1.5×ULN; left ventricular ejection
fraction (LVEF) = 50%; thyroid stimulating hormone (TSH) within the normal range
Within: if the baseline TSH exceeds the normal range, subjects with total T3 (or FT3)
and FT4 within the normal range can also be enrolled;
- Subjects of childbearing potential must use an appropriate method of contraception
during the study period and within 120 days after the end of the study, have a
negative serum pregnancy test within 7 days prior to study enrollment, and must be
non-lactating subjects;
Exclusion Criteria:
- Suffered from other malignant tumors within 5 years before the start of treatment in
this study;
- Grade =1 unresolved toxicities (according to the most recent version of the National
Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]) due to
any prior therapy, excluding alopecia and fatigue; neurotoxicity was Recovery to =
grade 1 or baseline before the group;
- Subjects with any severe and/or uncontrolled disease ;
- Poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L) ;
- Received major surgical treatment, incisional biopsy, or significant traumatic injury
within 28 days prior to the start of study treatment; or had a long-term unhealed
wound or fracture;
- Serious arterial/venous thrombotic event within 6 months prior to initiation of study
treatment ;
- Previously received drug therapy against PD-1, PD-L1 and other related immune
checkpoints ;
- Participating in or participating in other clinical investigators within 4 weeks prior
to the start of the study ;
- Allergic to the active ingredients or excipients of the study drug ;
- Unsuitable for the study or other chemotherapy determined by investigator.
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