Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Conditions
Keywords
Raltitrexed, Paclitaxel, chemotherapy, Gastric cancer, Gastroesophageal Junction Adenocarcinoma
Brief summary
This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary endpoint of this study is objective response rate.The secondary endpoint of this study is safety,progression-free survival and overall survival.
Detailed description
Raltitrexed is an antifolate thymidylate synthase inhibitor that has shown efficacy and good safety profile in the treatment of colorectal cancer. To our knowledge, there has been no study published with the Raltitrexed and Paclitaxel regimen as second-line chemotherapy for patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.The aim of our study was to evaluate the efficacy, safety and survival of this regimen in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Interventions
DRUGRaltitrexed
Raltitrexed:3mg/m2,iv,d1, Every 3 weeks
DRUGPaclitaxel
Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; * Patients failed first-line chemotherapy containing fluoropyrimidines and platinums; * ECOG (Eastern Cooperative Oncology Group)performance status 0-1; * At least 1 measurable lesion should be present（RECIST1.1） * Available Organ function: Neutrophils\>2g/L, Hemoglobin\>9g/L, Blood platelet \>100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)\<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)\<1.0 ULN; Cr \<1.0ULN * Signed informed consent. * Life expectancy ≥3 months;
Exclusion criteria
* Previous treatment with Raltitrexed or Paclitaxel; * Known history of allergic reaction to Raltitrexed or Paclitaxel; * Known brain metastases; * Pregnant or breast feeding women; * Severe diarrhea,intestinal obstruction; * other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix); * Previous myocardial infarction, unstable angina, stroke ,or uncontrollable Arrhythmia; * Kown HIV infecton.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | 18-26 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 18-26 months | From date of randomization until date of death |
| Progression-free survival | 18-26 months | From date of randomization until date of first documented PD, date of death |
Countries
China
Outcome results
None listed