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

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04140318
Collaborator
Chinese PLA General Hospital (Other), Beijing Friendship Hospital (Other), Beijing Hospital (Other)
60
1
1
38.6
1.6

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 15, 2019
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment

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

Drug: sintilimab
Sintilimab 200mg, iv, 30-60min, q3w;

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

Outcome Measures

Primary Outcome Measures

  1. ORR [up to two years]

Secondary Outcome Measures

  1. DCR [up to three years]

    disease control rate

  2. DOR [up to three years]

    duration of response

  3. AE [from first dose to 90days of last dose]

    treatment related adverse event

  4. PFS [up to three years]

    progression free survival

  5. OS [up to three years]

    overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese Academy of Medical Sciences Beijing China 10000

Sponsors and Collaborators

  • Chinese Academy of Medical Sciences
  • Chinese PLA General Hospital
  • Beijing Friendship Hospital
  • Beijing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aiping Zhou, Prof., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT04140318
Other Study ID Numbers:
  • NCC2070
First Posted:
Oct 25, 2019
Last Update Posted:
Mar 11, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aiping Zhou, Prof., Chinese Academy of Medical Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022