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

Recruiting

• Conditions: Unresectable Gastric Cancer

• Registration Number: NCT05385809
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-23
• Study Start: 2022-06-01
• Primary Completion: 2022-07-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical conversion rate	two years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China