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

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jianjun Yang
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Oxaliplatin; Paclitaxel

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