Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma Clinical Trial
Official title:
Efficacy and Safety of Sintilimab and Nab-paclitaxel in Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma Patients With Progression After Fluoropyrimidine or Platinum, a Multi-center, Phase II, Single Arm Trial
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | February 1, 2023 |
| Est. primary completion date | August 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Chinese Academy of Medical Sciences | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese Academy of Medical Sciences | Beijing Friendship Hospital, Beijing Hospital, Chinese PLA General Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ORR | up to two years | ||
| Secondary | DCR | disease control rate | up to three years | |
| Secondary | DOR | duration of response | up to three years | |
| Secondary | AE | treatment related adverse event | from first dose to 90days of last dose | |
| Secondary | PFS | progression free survival | up to three years | |
| Secondary | OS | overall survival | up to three years |