Clinical trial · Interventional
Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer
Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer, a Small-scale, Exploratory Real-world Study
NCT05052931CI-TRIAL-00065608unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nab-paclitaxel combined with oxaliplatin and S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- Nab-paclitaxel combined with oxaliplatin and S-1
- interventionNames
- Drug: Nab-paclitaxel combined with oxaliplatin and S-1
Primary outcomes (1)
- measure
- AE
- timeFrame
- 2-year
- description
- Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0
Secondary outcomes (3)
- measure
- Objective response rate (ORR)
- timeFrame
- 7-month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZheng 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