This study is to evaluate the efficacy and safety of Albumin-bound paclitaxel combined with Toripalimab as first-line/second-line treatment of local advanced or metastatic gastric or gastroesophageal junction carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
* 125mg/m2 IV d1、8,Q3W * until disease progression, lost follow-up visit, death , unacceptable toxicity
* 240 mg,IV d1,Q3W * until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration is 24 months
The First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGPFS
* Progression-Free Survival * Defined as the time from first dose of study medication to the first documented disease progression per RECIST version 1.1,or death from any cause, whichever occurred first
Time frame: up to 24 months
ORR
* Objective Response Rate * Defined as the proportion of patients with confirmed complete response /partial response per RECIST version 1.1
Time frame: up to 24 months
DCR
* Disease control rate * Defined as the proportion of patients with confirmed complete response /partial response/ Stable Disease per RECIST version 1.1
Time frame: up to 24 months
OS
* Over survival * Defined as the time from the date of first dose of study medication to the date of death from any cause
Time frame: up to 24 months
Change in Quality of Life(QoL):measured by EORTC QLQ-C30 questionnaire
* European Organisation for Research and Treatment of Cancer's Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) * The change in the quality of life as measured by EORTC QLQ-C30, consists of 30 questions that provide a global QoL scale, five functional scales (physical, role-playing, emotional, cognitive, social), three symptom scales (fatigue, nausea and vomiting, pain) and six individual factors (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). The scores of each scale are calculated in a score ranging from 0 to 100. A high score on a functional scale represents a good level of function.
Time frame: up to 24 months
Adverse events
\- Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
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Time frame: up to 24 months