| Eligibility |
Inclusion Criteria:
- 1. Age: 18 years old = age = 75 years old, both male and female;
- 2.Pathology (including histology or cytology) confirmed gastric adenocarcinoma
(papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma
muc, signet ring cell carcinoma sig, poorly differentiated adenocarcinoma por), and
HER2- (HER2 Negative: IHC 0/1+ or IHC2+ but ISH negative);
- 3. Confirm the diagnosis of gastric cancer peritoneal metastasis by laparoscopy,
laparotomy or imaging examination;
- 4. According to the RECIST1.1 standard, the patient has at least one target lesion
with measurable diameter (the long diameter of the CT scan of the tumor lesion is
=10mm, the short diameter of the CT scan of the lymph node lesion is =15mm, and the
scan slice thickness is 5mm;)
- 5. The damage caused by the patient's other treatments has recovered, and the interval
between receiving nitroso or mitomycin is = 6 weeks; receiving other cytotoxic drugs,
radiotherapy or surgery = 4 weeks, and the wound has been completely healed;
- 6. ECOG PS: 0-2;
- 7.Expected survival = 12 weeks;
- 8. The main organs function normally and meet the following criteria:
1. Routine blood: (no blood transfusion within 14 days):
1. HB=100g/L,
2. WBC=3×109/L,
3. ANC=1.5×109/L,
4. PLT=100×109/L;
2. Blood biochemistry:
1. BIL <1.5ULN,
2. ALT and AST <2.5ULN, GPT=1.5×ULN,
3. Serum Cr=1ULN, endogenous creatinine clearance rate >60ml/min
(Cockcroft-Gault formula),
4. ALB=30g/L;
- 9. Women of childbearing age must undergo a pregnancy test (serum) within 7 days
before enrollment, and the result is negative, and are willing to use appropriate
methods of contraception during the trial and 8 weeks after the last administration of
the trial drug; for men, surgical sterilization or Agree to use an appropriate method
of contraception during the trial and 8 weeks after the last administration of the
trial drug;
- 10. Not participating in other clinical studies before and during treatment;
- 11. The patients voluntarily joined the study, signed the informed consent to
participate in the experimental treatment, and agreed to participate in the
observational study, with good compliance and cooperation with follow-up;
- 12. Has a quantifiable CT-PCI score.
Exclusion Criteria:
- 1. Patients who have previously received treatment with albumin-paclitaxel, Sigio, and
camrelizumab; or patients who have previously received other immunotherapy (including
other clinical research drugs) within 5 half-lives from the first study drug;
- 2. Concomitant Difficulties in swallowing, complete or incomplete gastrointestinal
obstruction, active bleeding in the gastrointestinal tract, perforation, etc., etc.;
- 3. Participating in other clinical studies within 1 month before enrollment and the
toxicity has not recovered;
- 4. There are a large number of Patients with ascites requiring frequent drainage that
interferes with normal treatment;
- 5. Suffering from any active autoimmune disease or history of autoimmune disease (such
as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis,
myocarditis, nephritis, hyperthyroidism, hypothyroidism , including but not limited to
these diseases or syndromes); patients requiring no intervention in adulthood, except
for vitiligo or cured childhood asthma/allergies; autoimmune-mediated hypothyroidism
treated with stable doses of thyroid replacement hormones ; Type I diabetes mellitus
using stable doses of insulin;
- 6. A history of immunodeficiency, including HIV test positive, or other acquired or
congenital immunodeficiency diseases, or a history of organ transplantation and
allogeneic bone marrow transplantation;
- 7. Accompanied by severe heart, lung, liver and kidney diseases; neurological and
mental diseases; jaundice or gastrointestinal obstruction and concomitant severe
infection;
- 8. pregnant or breastfeeding women;
- 9. The presence of uncontrolled or symptomatic active central nervous system (CNS)
metastases, which can manifest as clinical symptoms, cerebral edema, spinal cord
compression meningitis, leptomeningeal disease, and/or progressive growth. CNS
metastases are adequately treated, and neurological symptoms can return to baseline
levels at least 2 weeks before enrollment (residual signs or symptoms associated with
CNS treatment can be enrolled in the study). In addition, patients must discontinue
corticosteroids or receive =10 mg/d of stable or tapered doses of prednisone (or
equivalent doses of other corticosteroids) at least 2 weeks prior to enrollment;
- 10. Patients with grade I or above coronary heart disease, arrhythmia (including QTc
interval prolongation > 450 ms in men, > 470 ms in women) and cardiac insufficiency;
- 11. Patients with clear gastrointestinal bleeding tendency, including the following
conditions: Patients with locally active ulcer lesions, fecal occult blood (++), and a
history of melena and hematemesis within 2 months; patients with abnormal coagulation
function (INR>1.5, APTT>1.5 ULN);
- 12. The patient has uncontrolled cardiovascular clinical symptoms or diseases,
including but not limited to: (1) NYHA class II heart failure (2) unstable angina
pectoris (3) myocardial infarction within 1 year (4) ) Clinically significant
supraventricular or ventricular arrhythmia without clinical intervention or still
poorly controlled after clinical intervention;
- 13. History of interstitial lung disease (except radiation pneumonitis without hormone
therapy), non-infectious pneumonia medical history;
- 14. Patients with positive urine protein (urinary protein test 2+ or above, or 24-hour
urine protein quantification >1.0g);
- 15. Those who are allergic to the experimental drug or its excipients;
- 16. those who are considered unsuitable for inclusion by the researchers.
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