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

Unresectable Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385809
• Other study ID #: IRB-2022-278
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Zhejiang Cancer Hospital
• Contact: Pengfei Yu, MD, PhD
• Phone: 86-571-88128031
• Email: ypfzmu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasms
• Unresectable Gastric Cancer

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	Innovent Biologics, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical conversion rate		two years
Secondary	R0 resection rate	Defined as no residue under the microscope after resection	two years
Secondary	Major pathological response (MPR)	MPR is defined as less than 10% residual tumor after neoadjuvant therapy	two years
Secondary	Overall response rate ( ORR)	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	two years
Secondary	adverse event (AEs)		two years