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

Primary Purpose

Gastric Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Nab-paclitaxel combined with oxaliplatin and S-1

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The First Affiliated Hospital of the Air Force Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

Nab-paclitaxel combined with oxaliplatin and S-1

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0

Secondary Outcome Measures

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.

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.

Overall survival (OS)

It is defined as the time from the first doses durg to the time of death due to any reason.

Full Information

NCT ID

NCT05052931

First Posted

August 25, 2021

Last Updated

April 12, 2023

Sponsor

Jianjun Yang

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05052931

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jianjun Yang

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Arm Description

Nab-paclitaxel combined with oxaliplatin and S-1

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel combined with oxaliplatin and S-1

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0

Time Frame

2-year

Secondary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

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.

Time Frame

7-month

Title

Disease Control Rate (DCR)

Description

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.

Time Frame

7-month

Title

Overall survival (OS)

Description

It is defined as the time from the first doses durg to the time of death due to any reason.

Time Frame

2-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

The First Affiliated Hospital of the Air Force Medical University

City

Xi'an

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jianjun Yang

Phone

029-84771532

yangjj@fmmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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