Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma
NCT ID: NCT04140318
Last Updated: 2022-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2019-11-15
2023-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment
combination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w
sintilimab
Sintilimab 200mg, iv, 30-60min, q3w;
nab-paclitaxel
Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w
Interventions
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sintilimab
Sintilimab 200mg, iv, 30-60min, q3w;
nab-paclitaxel
Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Beijing Friendship Hospital
OTHER
Beijing Hospital
OTHER_GOV
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Aiping Zhou
Prof.
Locations
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Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCC2070
Identifier Type: -
Identifier Source: org_study_id
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