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

Phase 2

Recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: Nab-paclitaxel combined with oxaliplatin and S-1

• Registration Number: NCT05052931
• Lead Sponsor: Jianjun Yang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-09-12
• Study First Posted: 2021-09-22
• Study Start: 2021-10-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Nab-paclitaxel combined with oxaliplatin and S-1	Nab-paclitaxel combined with oxaliplatin and S-1

Primary Outcome Measures

Name	Time	Method
AE	2-year	Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	7-month	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.
Objective response rate (ORR)	7-month	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.
Overall survival (OS)	2-year	It is defined as the time from the first doses durg to the time of death due to any reason.

Trial Locations

Locations (1)

The First Affiliated Hospital of the Air Force Medical University; 🇨🇳 Xi'an, China