Clinical trial · Interventional
Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
NCT03801668CI-TRIAL-00055777unknownPhase 3ClinicalTrials.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)
It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-bound Paclitaxel plus S-1 | Drug | — | UNRESOLVED |
| Oxaliplatin plus S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nab-P/S-1
- description
- Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.
- interventionNames
- Drug: Albumin-bound Paclitaxel plus S-1
- type
- ACTIVE_COMPARATOR
- label
- SOX
- description
- Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.
- interventionNames
- Drug: Oxaliplatin plus S-1
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age of 18-75 years; 2. Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma; 3. At least one measurable lesion as defined by RECIST 1.1 criteria; 4. ECOG performance status of 0-1; 5. Estimated life expectancy of at least 3 months; 6. Left ventricular ejection fraction (LVEF) ≥ 50%; 7. Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L; 8. Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases,total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome; 9. Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study; 10. Able and willing to comply with the study plans in this protocol and sign the informed consent; Exclusion Criteria: 1. Have received chemotherapy before;patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed\>6 months prior to first recurrence or metastasis; 2. HER-2 positive; 3. Patients with symptomatic brain metastases; 4. II-IV peripheral neuropathy \[NCI-CTCAE 4.03\]; 5. Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive; 6. Patients with serious systemic infection or other diseases; 7. Allergic to the chemotherapy drugs or the materials in this study; 8. Patients with gastrointestinal bleeding that need clinical intervention; 9. Patients with digestive tract obstruction or oral nutrition difficulty; 10. Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer; 11. Have participated in other clinical trials within 28 days prior to the first dose of this study; 12. Contraindications to chemotherapy; 13. Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.
References
Publications (1)
- DERIVEDDai YH, Yu XJ, Xu HT, Zhuang L, Zhang MS, Zou YM, Fu Q, Qiu H, Yuan XL. Nab-paclitaxel plus S-1 versus oxaliplatin plus S-1 as first-line treatment in advanced gastric cancer: results of a multicenter, randomized, phase III trial (GAPSO study). Ther Adv Med Oncol. 2022 Aug 12;14:17588359221118020. doi: 10.1177/17588359221118020. eCollection 2022. PMID 35983025