Clinical trial NCT05052931: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2021-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: AE
timeFrame: 2-year
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 7-month
measure: Disease Control Rate (DCR)
timeFrame: 7-month
measure: Overall survival (OS)
timeFrame: 2-year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of the Air Force Medical University
Study officials:
References: