Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer

Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer, a Small-scale, Exploratory Real-world Study

This is a prospective, single-center, open, historically controlled real-world study.

The aims of this study is to evaluate the safety and effectiveness of Nab-paclitaxel combined with oxaliplatin and S-1 in the treatment of patients with advanced gastric cancer.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Nab-paclitaxel combined with oxaliplatin and S-1

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Xi'an, China
    • Recruiting
    • the First Affiliated Hospital of the Air Force Medical University
    • Contact: Jianjun Yang; Phone Number: 029-84771532; Email: yangjj@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Gastric adenocarcinoma diagnosed by histology.
• Ambulatory cases, 18-75 years old
• ECOG performance status ≤ 1
• Have not received anti-tumor therapy previously (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
• Patients able to tolerate abdominal surgery above grade 3

• Has adequate organ function as defined by the following criteria:

  • WBC> 4.0×10^9/L
  • ANC> 1.5×10^9/L
  • ANC ≥ 1.5×10^9/L
  • HB ≥ 80 g/L
  • PLT ≥ 100×10^9/L
  • TBIL ≤ 1.5×ULN
  • ALT and AST <2.5 × ULN, for patients with liver metastases, ALT and AST <5 × ULN
  • BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min
• No history of other tumors
• Be willing and able to comply with the plan during the research period
• Has given written informed consent
• Life expectancy ≥ 6 months

Exclusion Criteria:

• Those with a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ
• HER-2+ and willing to receive Trastuzumab
• Pregnancy or breast-feeding women; Men and women who are sexually active (possible to have children) and unwilling to use contraception during the study period
• Severe, uncontrolled medical diseases and infections; chronic bowel disease or short bowel syndrome
• Major organ failure, such as compensatory cardiopulmonary liver and kidney failure; severe liver and kidney metabolism abnormalities, affecting the normal metabolism of drugs
• Patients with other surgical contraindications, such as serious diseases that are difficult to control
• The researcher believes that patients with a clear gastrointestinal bleeding tendency and/or patients with abnormal blood coagulation function (INR > 1.5)
• Active HBV or HCV
• Peripheral neuropathy ≥ Grade 2 according to NCT-CTC AE5.0
• Patients who are allergic to the drugs in this study, or determined by the investigator as unsuitable to participate in this clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; Nab-paclitaxel combined with oxaliplatin and S-1	Drug: Nab-paclitaxel combined with oxaliplatin and S-1; Nab-paclitaxel 100mg/m^2, D1, Q3W; oxaliplatin 85 mg/m^2, D1, Q3W; S-1 60 mg/m^2, D1-14, Q3W; Neoadjuvant chemotherapy 2 cycles, followed by surgery, continue to receive 6 cycles of adjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE	Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0	2-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defined as the rate of complete response (CR) or partial response (PR), as determined by IRC using RECIST v1.1 criteria among patients with at least one target lesion.	7-month
Disease Control Rate (DCR)	The proportion of all subjects who assessed the best overall curative effect as CR, PR, and disease stable (SD) according to the RECIST 1.1 standard.	7-month
Overall survival (OS)	It is defined as the time from the first doses durg to the time of death due to any reason.	2-year

Collaborators and Investigators

• Sponsor: Jianjun Yang
• Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 12, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Oxaliplatin
• Other Study ID Numbers: CSPC-KIL-GC-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No