Prediction of the Efficacy of ctDNA in Immunotherapy for Advanced Gastric Cancer

NCT04053725 | Unknown DMC

• 1 other identifier: SYSUCC-ctDNA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer is one of the common malignant tumors in China, with relatively high incident rate and mortality among the population. Surgery is the conventional treatment option for early and intermediate-stage stage gastric cancer, but postoperative relapse is the major issue. Circulating tumor DNA (ctDNA) is tumor-derived fragmented DNA with an average size of 166 bp, mixed with cell free DNA (cfDNA) of other sources in blood circulation.ctDNA is reflecting the most up-to-date status of tumor genome. Hence, it is considered as a new biomarker for tumor, which can be qualitative, quantitative and used for disease monitoring. The present clinical trial aims to explore the possibility of clinical utility of serum ctDNA as a clinical index to predict the efficacy in immunotherapy for advanced gastric cancer.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• the proportions of patients with positive serum ctDNA that have postoperative relapse

  the proportions of patients with positive serum ctDNA (in any follow-up) that have postoperative relapse

  through study completion, an average of 2 years

Secondary Outcomes (1)

• The proportion of ctDNA content decreased in patients with good therapeutic effect

  through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This prospective clinical study program enrolled 80 patients. Patients should be treated with second- or third-line chemotherapy and combined with immunoassay inhibitors. The pre-treatment plasma ctDNA sample mutation information of each patient was compared with the tissue sample mutation information. The pre-treatment ctDNA dynamic monitoring results were compared with the ctDNA mutation information after treatment initiation. The post-treatment ctDNA dynamic monitoring results and imaging comparison analysis.

You may qualify if:

• Male or female ≥ 18 years of age at first visit.
• Patients must have histologically confirmed gastric cancer .
• Patients were surgically assessed to be inoperable.
• Patients received second-line or third-line chemotherapy and were treated with immunoassay point inhibitors.
• Patients' early pathological information was complete, including tumor site and pathological type.
• Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS analysis.
• Patients must be able to follow the study visit schedule and willing to provide peripheral blood samples at the indicated time point.
• Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

You may not qualify if:

• Patients who cannot provide peripheral blood samples prior to the surgical treatment will be excluded.
• Patients with severe infection will be excluded.
• Patients with other serious disease besides gastric cancer will be excluded.
• Pregnant women will be excluded.
• Patients who are alcoholic or drug abusers will be excluded.
• Patients with a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data will be excluded.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Rui-hua Xu

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongsheng Zhang, MD.,PhD.

CONTACT

86-2087343804; Zhangdsh@sysucc.org.cn

Zhida Lv, BS.

CONTACT

86-2087343795; lvzd@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: president

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: August 12, 2019
• Study Start: February 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: November 1, 2021
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

CN (1)