Clinical trial NCT04140318: Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma
Keywords: second line
PD-1
nab-paclitaxel
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Chinese PLA General Hospital
name: Beijing Friendship Hospital
name: Beijing Hospital
First posted: 2019-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ORR
timeFrame: up to two years
Secondary outcomes:
measure: DCR
timeFrame: up to three years
measure: DOR
timeFrame: up to three years
measure: AE
timeFrame: from first dose to 90days of last dose
measure: PFS
timeFrame: up to three years
measure: OS
timeFrame: up to three years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences
Study officials:
References: