Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Unknown

Phase 2

Conditions

Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma

Treatments

Drug: sintilimab

Drug: nab-paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT04140318

NCC2070

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.