Clinical trial NCT05410847: Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
Official title: A Prospective Study of Intraperitoneal and Intravenous Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous nab-paclitaxel plus Camrelizumab and S-1 conversion therapy for gastric cancer with positive exfoliative cancer cells.


Eligibility criteria: Inclusion Criteria:

1. None previous chemotherapy, radiotherapy and other antitumor therapy;
2. Age:18 to 70 years old;
3. Man or female (except pregnant and lactating women);
4. Conﬁrmed to gastric adenocarcinoma and HER2-negative;
5. Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
6. Blood cell count has to meet the following certeria:

   WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
7. Liver/kidney function has to meet the following certeria:

   ALT and AST≤2.5×ULN TBIL\<1.5×ULN； Serum creatinine ≤1.5×ULN;
8. Left ventricular ejection fraction (LVEF) ≥50%;
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
10. Participants were willing to join in this study, good adherence and written informed consent.

Exclusion Criteria:

1. Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
2. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
3. Patients with other malignant tumors within 5 years;
4. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study;
5. Distant metastasis;
6. It has serious or uncontrolled medical diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
7. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
8. Patients with severe or uncontrollable mental illness;
9. It have serious harm to the patient's safety or affect the patients who have completed the research.
10. The researchers think inappropriate.

Primary outcomes:
measure: R0-resection rate
timeFrame: within 3 weeks after surgery
measure: Conversion to negative rate
timeFrame: within 3 weeks after surgery
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3years
measure: Progression free survival (PFS)
timeFrame: 3years
measure: Objective response rate (ORR)
timeFrame: tumor assessment every 6 weeks since the treatment began，up to 3years
measure: Disease control rate (DCR)
timeFrame: tumor assessment every 6 weeks since the treatment began，up to 3years
measure: Tumor regression grade (TRG)
timeFrame: within 3 weeks after surgery
measure: Adverse events
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References: