Overview

Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer

Status:
Completed
Trial end date:
2017-02-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the effectiveness and safety of s-1 plus Albumin Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the stomach with inoperable locally
advanced or recurrent and/or metastatic disease.

- Male or female.

- Age ≥ 18.

- No previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant
therapy is allowed if at least 6 months has elapsed between completion of
adjuvant/neoadjuvant therapy and enrolment into the study).

- 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:

- Prior palliative chemotherapy.

- Received any investigational drug treatment within 30 days of start of study
treatment.

- Patients with active gastrointestinal bleeding.

- 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.

- Neurological toxicity ≥ grade 2 NCI-CTCAE.