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

A Retrospective Study of Sintilimab Combined With Chemotherapy in Conversion Therapy of Unresectable Locally Advanced or Stage IV Gastric Cancer/Gastroesophageal Junction Carcinoma

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05385809

Enrollment

100

Registered

2022-05-23

Start date

2022-06-01

Completion date

2023-12-31

Last updated

2022-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Gastric Cancer

Keywords

Unresectable Gastric Cancer, Conversion Therapy, Immunotherapy, Sintilimab

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Surgical conversion rate	two years

Secondary

Measure	Time frame	Description
R0 resection rate	two years	Defined as no residue under the microscope after resection
Major pathological response (MPR)	two years	MPR is defined as less than 10% residual tumor after neoadjuvant therapy
Overall response rate ( ORR)	two years	ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment
adverse event (AEs)	two years	—

Countries

China

Contacts

Primary ContactPengfei Yu, MD, PhD

ypfzmu@163.com86-571-88128031

Outcome results