| Eligibility |
Inclusion Criteria:
1. Histologically or cytologically confirmed advanced peritoneal metastatic carcinoma of
gastrointestinal or primary peritoneal cancer
2. Failed after standard treatment
3. Have evaluable lesions, including those that are not measurable
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. Adequately understand the study and voluntarily sign the Informed Consent Form;
6. =18 years old;
7. Lab tests within 7 days before first dose:
1) Absolute neutrophil count (ANC) =1.5×109/L, platelet count =100×109/L, and hemoglobin
=100g/L; 2) Serum total bilirubin =1.5 times the upper limit of normal (ULN); 3) Alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) levels =2.5 times the ULN; 4)
Patients without anticoagulant therapy: International Normalized Ratio (INR) =1.5 ULN and
activated partial thromboplastin time (APTT) =1.5 ULN. If patients received anticoagulant
therapy: INR =2 ULN and APTT was within the normal range 14 days before treatment; 5) Serum
total bilirubin <1.5 times the upper limit of normal (ULN); 6) Urine protein < 2+; if =2+,
24-hour urine protein <1 g; 8. Male or females patients with reproductive potential must
agree to use an effective contraceptive method, for example, double-barrier device, condom,
oral or injected birth control medication or intrauterine device, during the study and
within 90 days after study treatment discontinuation. All female patients are considered to
be fertile, unless the patient had natural menopause or artificial menopause or
sterilization (such as hysterectomy, bilateral oophorectomy or ovarian irradiation).
Exclusion Criteria:
1. Prior system treatment with antiPD1/PDL1/PDL2/CTLA-4 antibody or Sulfatinib;
2. Previous intraperitoneal treatment with immunologic agents;
3. Patients with digestive tract obstruction or uncontrolled active bleeding from the
primary tumor;
4. Patients with any active autoimmune disease or a documented history of autoimmune
disease: Patients with hypothyroidism but receiving a stable dose of thyroid hormone
replacement therapy were included in the study, and subjects with stable type 1
diabetes were able to control their blood sugar;
5. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis,
drug-associated pneumonia, severe impaired lung function, etc;
6. Prior major surgery within past 4 weeks and had not fully recovered from previous
surgery;
7. Active bleeding or abnormal coagulation, Prone to bleeding or receiving thrombolytic
or anticoagulant therapy;
8. Hypertension that is not controlled by the drug, and is defined as: SBP=140 mmHg
and/or DBP=90 mmHg;
9. Prior antitumor therapy (including chemotherapy, immunotherapy, biological treatment,
Targeted therapy, etc) , or have not recovered from toxicities since the last
treatment;
10. Pregnant or nursing;
11. previously received allogeneic stem cell or parenchymal organ transplantation;
12. Any significant clinical or laboratory abnormality that the investigator considers to
influence the safety evaluators;
13. History of uncorrected serum electrolyte disturbances such as potassium, calcium, or
magnesium;
14. Known human immunodeficiency virus (HIV) infection;
15. Active hepatitis B virus (HBV) and hepatitis C virus (HCV) infected persons;
16. A history of other malignancies within 5 years prior to inclusion, except for cervical
carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer
treated with radical surgery, and ductal carcinoma in situ treated with radical
surgery;
17. Prior treatment with corticosteroids (dose > 10 mg/day prednisone or other hormones)
or other immunosuppressive agents within 2 weeks, nasal or inhalation in allowed (dose
> 10 mg/day prednisone or other hormones);
18. Severe, uncontrolled medical condition that would affect patients' compliance or
obscure the interpretation of toxicity determination or adverse events, including
active severe infection, uncontrolled diabetes, angiocardiopathy (heart failure >
class II NYHA, LVEF <50%, myocardial infarction, unstable arrhythmia or unstable
angina within past 6 months, cerebral infarction within past 3 months) or pulmonary
disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic
bronchospasm);
19. History with tuberculosis who are receiving or have received anti-TB treatment within
1 year;
20. Active infection;
21. Receiving another experimental drug or participating in a clinical study for another
therapeutic purpose within the first 28 days prior to treatment initiation;
22. Any other disease, metabolic disorder, abnormal results of a physical examination or
laboratory examination, and reasonably suspected disease or condition that may
contraindication the use of the investigational drug, or affect the reliability of the
study results, or place the patient at high risk for treatment complications, or
affect patient compliance.
|
