Overview

Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis:Single-arm, Prospective Clinical Study

Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhongshan Hospital Xiamen University
Collaborator:
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Treatments:
Paclitaxel
Criteria
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.