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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05052931
• Other study ID #: CSPC-KIL-GC-006
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of the Air Force Medical University	Xi'an

Sponsors (2)

Lead Sponsor	Collaborator
Jianjun Yang	CSPC Ouyi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AE	Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0	2-year
Secondary	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
Secondary	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
Secondary	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