The Efficacy of Precision Treatment for Gastric Cancer Guided by Molecular Profiling

The Efficacy of Precision Treatment for Gastric Cancer Guided by Multidimensional Molecular Biology Profiling: a Multi-center Clinical Study

Gastric cancer (GC) is one of the most common and lethal cancers worldwide, especially in China, and the median overall survival for patients with advanced, metastatic GC remains only about 1 year. Several molecular profiling studies have demonstrated that a proportion of gastric cancer harbour actionable molecular alterations which shows a predictive benefit from a specific therapy (in any cancer type). In the current study, the efficacy of precision treatment for gastric cancer guided by multidimensional molecular biology profiling will be observed. The analysis focused on the overall survival outcomes for patients whose tumours harboured actionable molecular alterations and who received appropriately matched therapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Cancer

• Study Type: Observational
• Enrollment (Anticipated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with biopsy-confirmed gastric cancer at stage IV who conducted molecular testing are included.

Description

Inclusion Criteria:

1. Male or female. Age: 18-80 years.
2. Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy.
3. Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, assessed using imaging techniques (CT or MRI).
4. Multidimensional molecular biology profiling has been conducted using tumor or blood sample.
5. ECOG Performance status 0-1.
6. Life expectancy of at least 3 months.
7. Signed informed consent.

Exclusion Criteria:

1. The quality of NGS reports does not fit the requirement.
2. History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias.
3. Baseline LVEF < 50% (measured by echocardiography or MUGA).
4. Patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy.
5. Patients receiving chronic or high dose corticosteroid therapy. (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed).
6. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
7. History or clinical evidence of brain metastases.
8. Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes.
9. Positive serum pregnancy test in women of childbearing potential.
10. Subjects with reproductive potential not willing to use an effective method of contraception.
11. Major surgery within 4 weeks of start of study treatment, without complete recovery.
12. Patients with known active infection with HIV, HBV, or HCV.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Matched therapy; Molecular profiling performed with actionable molecular alterations detected and target therapy was then conducted
Unmatched therapy; Molecular profiling performed with actionable molecular alterations detected but therapy was conducted based on the guideline treatment
No marker; Molecular profiling performed without any actionable molecular alterations detected, tranditional therapy based on the guideline was then conducted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival was measured from the date of advanced disease until death.	up to 3 years
Progression-free survival	The PFS was calculated from the date of advanced disease to the date of disease progression or death	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive rate	Actionable molecular alterations detected by molecular profiling	up to 3 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: gastric cancer; precision medicine
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: ZS-ON-100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No