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

Zhejiang Cancer Hospital100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Unresectable Gastric Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

Surgical conversion rate

Time frame: two years

Secondary Outcomes

R0 resection rate

Defined as no residue under the microscope after resection

Time frame: two years

Major pathological response (MPR)

MPR is defined as less than 10% residual tumor after neoadjuvant therapy

Time frame: two years

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

Time frame: two years

adverse event (AEs)

Time frame: two years

Central Contacts

Pengfei Yu, MD, PhD

CONTACT

86-571-88128031 ypfzmu@163.com

Data from ClinicalTrials.gov

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