Clinical trial · Interventional
Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer
NCT02229045CI-TRIAL-00015513unknownPhase 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)
The purpose of this study is to evaluate the effectiveness and safety of albumin bound paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive 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 Caner | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Albumin Bound Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Albumin Bound Paclitaxel With 5-FU/CF
- description
- Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
- interventionNames
- Drug: Albumin Bound Paclitaxel
- Drug: 5-FU
Primary outcomes (1)
- measure
- PFS(Progression-free survival )
- timeFrame
- 80% PFS events,, an expected average of 10 months
- description
- The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death
Secondary outcomes (1)
- measure
- OS (Overall survival )
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease. * Male or female. * Age 18 -75. * Previous one line of non-taxane chemotherapy for advanced/metastatic disease. * Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST) * ECOG Performance status 0, 1 or 2 * Haematological, Biochemical and Organ Function: Neutrophil count \>2.0 × 10 9/L, platelet count \> 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or \> 5 × ULN in patients with liver metastases,Creatinine clearance \> 60 mL/min. * Signed informed consent. Exclusion Criteria: * No prior chemotherapy for gastric cancer. * Received any investigational drug treatment within 30 days of start of study treatment. * Patients with active gastrointestinal bleeding. * Neurological toxicity ≥ grade 2 NCI-CTCAE. * Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. * History or clinical evidence of brain metastases. * Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. * Pregnancy women. * Subjects with reproductive potential not willing to use an effective method of contraception. * Patients with known active infection with HIV. * Known hypersensitivity to any of the study drugs
References
Publications (0)
Data not yet available
No reference posted for this study.