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

NCT05410847 | Unknown Phase 2

• 1 other identifier: HRCG-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• R0-resection rate

  There was no residual by the microscope

  within 3 weeks after surgery

• Conversion to negative rate

  Exfoliative cytology positive gastric cancer conversion to negative rate

  within 3 weeks after surgery

Secondary Outcomes (6)

• Overall survival (OS)

  3years

• Progression free survival (PFS)

  3years

• Objective response rate (ORR)

  tumor assessment every 6 weeks since the treatment began，up to 3years

• Disease control rate (DCR)

  tumor assessment every 6 weeks since the treatment began，up to 3years

• Tumor regression grade (TRG)

  within 3 weeks after surgery

Study Arms (1)

Experimental

EXPERIMENTAL

Camrelizumab: 200mg，iv，30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles. S-1：According to the body surface area, BSA \<1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA \>1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week, q3w, 4 cycles. For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year. Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator.

Drug: Camrelizumab Nab-Paclitaxel S-1

Interventions

Camrelizumab Nab-Paclitaxel S-1 DRUG

Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• None previous chemotherapy, radiotherapy and other antitumor therapy;
• Age:18 to 70 years old;
• Man or female (except pregnant and lactating women);
• Confirmed to gastric adenocarcinoma and HER2-negative;
• 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;
• 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;
• Liver/kidney function has to meet the following certeria:
• ALT and AST≤2.5×ULN TBIL\<1.5×ULN； Serum creatinine ≤1.5×ULN;
• Left ventricular ejection fraction (LVEF) ≥50%;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Participants were willing to join in this study, good adherence and written informed consent.

You may not qualify if:

• 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);
• 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);
• Patients with other malignant tumors within 5 years;
• 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;
• Distant metastasis;
• 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);
• History of psychiatric drugs abuse and can't quit or patients with mental disorders;
• Patients with severe or uncontrollable mental illness;
• It have serious harm to the patient's safety or affect the patients who have completed the research.
• The researchers think inappropriate.

Sponsors & Collaborators

• Hebei Medical University: lead

Related Publications (1)

• Lv J, Wu J, Wu H, Ding P, Guo H, Yang P, Tian Y, Liu Y, Zhao Q. Study protocol of a phase II clinical trial evaluating the efficacy of neoadjuvant intraperitoneal and systemic albumin-bound paclitaxel combined with camrelizumab and S-1 in the treatment of patients with exfoliative cell-positive gastric cancer. Front Oncol. 2023 Sep 29;13:1201928. doi: 10.3389/fonc.2023.1201928. eCollection 2023.

  PMID: 37841441 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Qun Zhao, Professor

CONTACT

13930162111; Zhaoqun516@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 8, 2022
• Study Start: June 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2025
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share