NCT04140318

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

2.8 years

First QC Date

October 24, 2019

Last Update Submit

March 9, 2022

Conditions

Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma

Keywords

second linePD-1nab-paclitaxel

Outcome Measures

Primary Outcomes (1)

  • ORR

    up to two years

Secondary Outcomes (5)

  • DCR

    up to three years

  • DOR

    up to three years

  • AE

    from first dose to 90days of last dose

  • PFS

    up to three years

  • OS

    up to three years

Study Arms (1)

treatment

EXPERIMENTAL

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

Drug: sintilimabDrug: nab-paclitaxel

Interventions

sintilimabDRUG

Sintilimab 200mg, iv, 30-60min, q3w;

treatment
nab-paclitaxelDRUG

Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w

treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • years old;
  • ECOG: 0 or 1;
  • has adequate organ function
  • writen ICF;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, 10000, China

RECRUITING

MeSH Terms

Interventions

sintilimab130-nm albumin-bound paclitaxel

Central Study Contacts

Aiping Zhou, MD

CONTACT

8687788145zhouap1825@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

October 24, 2019

First Posted

October 25, 2019

Study Start

November 15, 2019

Primary Completion

August 30, 2022

Study Completion

February 1, 2023

Last Updated

March 11, 2022

Record last verified: 2022-03

Locations

CN(1)