Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05410847
• Other study ID #: HRCG-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 30, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2022
• Source: Hebei Medical University
• Contact: Qun Zhao, Professor
• Phone: 13930162111
• Email: Zhaoqun516[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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. Con?rmed 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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Camrelizumab Nab-Paclitaxel S-1
Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0-resection rate	There was no residual by the microscope	within 3 weeks after surgery
Primary	Conversion to negative rate	Exfoliative cytology positive gastric cancer conversion to negative rate	within 3 weeks after surgery
Secondary	Overall survival (OS)	Baseline to measured date of death from any cause	3years
Secondary	Progression free survival (PFS)	Baseline to measured date of progression or death from any cause	3years
Secondary	Objective response rate (ORR)	Baseline to measured stable disease	tumor assessment every 6 weeks since the treatment began,up to 3years
Secondary	Disease control rate (DCR)	Baseline to measured progressive disease	tumor assessment every 6 weeks since the treatment began,up to 3years
Secondary	Tumor regression grade (TRG)	TRG included four grades: Grade 0-3	within 3 weeks after surgery
Secondary	Adverse events	Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of Participants with adverse events will be recorded at each treatment visit.	3 years