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

Jianjun Yang

Status and phase

Enrolling

Phase 2

Conditions

Gastric Cancer

Treatments

Drug: Nab-paclitaxel combined with oxaliplatin and S-1

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05052931

CSPC-KIL-GC-006

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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