Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma
Conditions
Keywords
second line, PD-1, nab-paclitaxel
Brief summary
To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.
Interventions
DRUGsintilimab
Sintilimab 200mg, iv, 30-60min, q3w;
DRUGnab-paclitaxel
Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w
Sponsors
Chinese PLA General Hospital
Beijing Friendship Hospital
Beijing Hospital
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
* pathological confirmed advanced gastric and gastro-esophageal junction adenocarcinoma; * progression after first-line treatment of fluoropyrimidine and platinum, allow patients progressed on/within 6 months of neoadjuvant/adjuvant treatment; allow local radiotherapy after 21days later; * 18-75 years old; * ECOG: 0 or 1; * has adequate organ function * writen ICF;
Exclusion criteria
* previous treated with taxanes (including paclitaxel, nab-PTX, lipo-PTX, and docetaxel etc..); * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody; * has known active central nervous system metastatases; * has received a live vaccine within 4 weeks prior to the first dose of study treatment with any acitve autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatititis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. * clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), orventricular arrhythmia which need medical intervention. * hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg. coagulation abnormalities (INR \> 1.5 or APTT \> 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR | up to two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | up to three years | disease control rate |
| DOR | up to three years | duration of response |
| AE | from first dose to 90days of last dose | treatment related adverse event |
| PFS | up to three years | progression free survival |
| OS | up to three years | overall survival |
Countries
China
Contacts
Primary ContactAiping Zhou, MD
Outcome results
None listed