NCT05385809

Brief Summary

This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

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

May 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

May 17, 2022

Last Update Submit

November 8, 2022

Conditions

Unresectable Gastric Cancer

Keywords

Unresectable Gastric CancerConversion TherapyImmunotherapySintilimab

Outcome Measures

Primary Outcomes (1)

  • Surgical conversion rate

    two years

Secondary Outcomes (4)

  • R0 resection rate

    two years

  • Major pathological response (MPR)

    two years

  • Overall response rate ( ORR)

    two years

  • adverse event (AEs)

    two years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 pantients with histologically confirmed GC/esophagogastric junction cancer (EGJC) who received immunotherapy prior to surgical resection

You may qualify if:

  • Ages: 18-75 Years (concluding 18 and 75 Years)
  • Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma
  • Unresectable, locally advanced or limited distant metastasis of IV gastric cancer(AJCC 8th)
  • Meets only ≤2 of the following conditions: highly locally advanced (T4b), or extensive or bulcky lymph nodes; Para-aortic lymph node metastasis(mainly 16A2/B1 region); limited liver metastasis(H1); limited Peritoneal metastasis(CY1, P1), with or without ovarian metastasis(Kukernburg tumor);
  • Untreated(e.g. radiotherapy, chemotherapy, target therapy, immunotherapy, et al.)
  • At least 1 measurable lesion by RECIST v1.1 criteria
  • ECOG PS: 0-2
  • Received sintilimab combined with chemotherapy(SOX or PS) at least 1 cycle

You may not qualify if:

  • Known Her2 positive
  • Patients with incomplete data or other factors affecting the judgment of efficacy and safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Study Officials

  • Xiangdong Cheng, MD, PhD

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Yu, MD, PhD

CONTACT

86-571-88128031ypfzmu@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 23, 2022

Study Start

June 1, 2022

Primary Completion

July 30, 2022

Study Completion

December 31, 2023

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

CN(1)