Liquid Biopsy in Monitoring the Therapeutic Efficacy of Targeted Therapy in Advanced/Metastatic Gastric Cancer

NCT02610218 | Unknown

• 1 other identifier: LiquidBiopsy
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in histologically confirmed HER2 positive advanced/metastatic gastric cancer.

Conditions

Gastric Cancer

Keywords

Cell free DNA; Circulating tumor cell; Therapeutic efficacy

Outcome Measures

Primary Outcomes (1)

• Correlation of HER2 status on CTCs and cfDNA with clinical outcomes

  To evaluate the correlation of CTCs and their HER2 expression status to the clinical outcomes

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Gene variations associated with resistance in HER2-targeted therapy

  up to 6 months

Study Arms (2)

histo-HER2+ gastric cancer patients

Histologically HER2 positive gastric cancer patients treated with HER2 targeted therapy. Interventions: peripheral blood samples of 12.5 mL for CTC and cfDNA analysis will be collected before targeted therapy, at the time that they achieve the optimal response and when they suffer progressive disease.

Other: CTC and cfDNA analysis

histo-HER2- gastric cancer patients

Histologically HER2 negative gastric cancer patients treated with chemotherapy. Interventions: peripheral blood samples of 12.5 mL for CTC and cfDNA analysis will be collected before targeted therapy, at the time that they achieve the optimal response and when they suffer progressive disease.

Other: CTC and cfDNA analysis

Interventions

CTC and cfDNA analysis OTHER

The enumeration of CTCs as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Further, for the geneomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

histo-HER2+ gastric cancer patients; histo-HER2- gastric cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Anticipated 124 patients with histologically confirmed HER2 positive advanced/metastatic gastric cancer

You may qualify if:

• Having signed informed consent
• Age≥ 18 years old
• Histologically confirmed HER2 positive gastric adenocarcinoma
• Unresectable recurrent or metastatic disease
• Measurable disease according to the RECIST criteria
• Karnofsky performance status ≥60
• Life expectancy of ≥2 month
• ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
• Serum albumin level ≥3.0g/dL
• Serum AKP \< 2.5 times ULN
• Serum creatinine \<ULN, and CCr \< 60ml/min
• Bilirubin level \< 1.5 ULN
• WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

You may not qualify if:

• Brain metastasis (known or suspected)
• Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry. Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
• Allergic constitution or allergic history to protium biologic product or any investigating agents.
• Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
• Pregnancy or lactation period
• Other previous malignancy within 5 year, except non-melanoma skin cancer
• Pre-existing neuropathy\>grade 1
• Legal incapacity

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Department of GI Oncology, Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples of 12.5 mL were collected from the patients for cfDNA and CTCs analysis

MeSH Terms

Conditions

Stomach Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of GI oncology

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: April 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

CN (1)