Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: treatment combination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w |
Drug: sintilimab
Sintilimab 200mg, iv, 30-60min, q3w;
Drug: nab-paclitaxel
Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w
|
Outcome Measures
Primary Outcome Measures
- ORR [up to two years]
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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pathological confirmed advanced gastric and gastro-esophageal junction adenocarcinoma;
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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;
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18-75 years old;
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ECOG: 0 or 1;
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has adequate organ function
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writen ICF;
Exclusion Criteria:
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previous treated with taxanes (including paclitaxel, nab-PTX, lipo-PTX, and docetaxel etc..);
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Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody;
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has known active central nervous system metastatases;
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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.
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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.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Chinese Academy of Medical Sciences | Beijing | China | 10000 |
Sponsors and Collaborators
- Chinese Academy of Medical Sciences
- Chinese PLA General Hospital
- Beijing Friendship Hospital
- Beijing Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCC2070