A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer

NCT ID: NCT05385809

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Unresectable Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Known Her2 positive
* Patients with incomplete data or other factors affecting the judgment of efficacy and safety
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics, Inc.

OTHER

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiangdong Cheng

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangdong Cheng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pengfei Yu, MD, PhD

Role: CONTACT

86-571-88128031

Facility Contacts

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Cheng Xiangdong, MD

Role: primary

+0086-571-88128041

Other Identifiers

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IRB-2022-278

Identifier Type: -

Identifier Source: org_study_id

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