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

Phase 2

• Conditions: Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma
• Interventions: Drug: sintilimab; Drug: nab-paclitaxel

• Registration Number: NCT04140318
• Lead Sponsor: Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Study Start: 2019-11-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-11
• Primary Completion: 2022-08-30
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	nab-paclitaxel	combination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w
treatment	sintilimab	combination therapy of PD-1 and chemotherapy including: sintilimab 200mg iv, 30-60min, q3w; nab-paclitaxel 125mg/m2, iv, d1,d8, q3w

Primary Outcome Measures

Name	Time	Method
ORR	up to two years

Secondary Outcome Measures

Name	Time	Method
OS	up to three years	overall survival
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

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China