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

NCT05052931 | Unknown Phase 2 DMC

• 1 other identifier: CSPC-KIL-GC-006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• AE

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

  2-year

Secondary Outcomes (3)

• Objective response rate (ORR)

  7-month

• Disease Control Rate (DCR)

  7-month

• Overall survival (OS)

  2-year

Study Arms (1)

treatment group

EXPERIMENTAL

Nab-paclitaxel combined with oxaliplatin and S-1

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

Interventions

Nab-paclitaxel combined with oxaliplatin and S-1 DRUG

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.

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jianjun Yang: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of the Air Force Medical University

Xi'an, China

RECRUITING

Related Publications (1)

• Zheng J, Wang S, Xu G, Wang J, Wang Y, Luo J, Wang Y, Yang J. A small-scale, exploratory real-world study of nab-paclitaxel combined with oxaliplatin and tegafur in the perioperative treatment of advanced gastric cancer: a study protocol for a real-world clinical trial. J Gastrointest Oncol. 2023 Apr 29;14(2):1131-1140. doi: 10.21037/jgo-23-131. Epub 2023 Apr 27.

  PMID: 37201078 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; S 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 22, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

CN (1)