The Efficacy of Immunodetection Point Inhibitors for Advanced Esophageal Cancer

NCT04074447 | Unknown DMC

• 1 other identifier: ctDNA-1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal cancer is one of the most common malignancies of the digestive system. Esophageal squamous cell carcinoma is the main type of esophageal cancer, accounting for more than 90% of esophageal cancer in China. The 5-year survival rate is about 15%\~25%. Many patients with esophageal cancer are initially diagnosed as advanced, and many patients with early initial diagnosis will still relapse and metastasis after radical treatment. Currently, chemotherapy plays a central role in palliative care, but its objective remission rate is only 20-40%, and the median survival is about 8-10 months. However, most of the current phase III studies on targeted drugs for esophageal squamous cell carcinoma have failed, and the treatment of esophageal squamous cell carcinoma has entered the bottleneck stage. Therefore, it is urgent to explore a treatment method that can significantly improve the prognosis of patients with esophageal cancer. In recent years, with the development of biological immunotherapy, immunocheckpoint inhibitors, including pd-1 inhibitors, pd-l1 inhibitors and ctla-4 inhibitors, have achieved significant curative effect and made breakthroughs in the treatment of multiple solid tumors including melanoma, non-small cell lung cancer and kidney cancer. These immunocheckpoint inhibitors have also been tried for esophageal cancer, with initial success in immunotherapy for esophageal cancer. In this observational study, all patients with esophageal cancer who used immunocheckpoint inhibitors in clinical practice were included, without limitation on the number of treatment lines or combinations of different chemotherapy. Through follow-up observation, the purpose of this study was to analyze the efficacy of immunocheckpoint inhibitors for esophageal cancer in the real world, and to explore the differences in the efficacy of immunocheckpoint inhibitors in different stages of treatment, as well as the efficacy of different chemotherapy combinations, so as to provide clinical evidence for the use of immunotherapy for advanced esophageal cancer.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

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

  The proportion of patients with good therapeutic effect whose serum ctDNA content decreased (in any follow-up）

  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

A total of 80 patients with advanced esophageal cancer were enrolled. Patients need to be treated with second - or third-line chemotherapy combined with immunocheckpoint inhibitors. 10ml of edta-anticoagulant blood was collected before the first treatment of the enrolled patients, and the blood samples were gently reversed in the anticoagulant tube for several times to fully anticoagulate. The upper plasma and the lower blood cells were centrifuged at 1800g for 10 min within 4 hours, respectively, and stored at -80 ℃ for later use and provide 5-10 tissue white sheets.

You may qualify if:

• age above 18, male or female.
• patients with esophageal cancer confirmed by pathology through tumor biopsy or puncture tissue.
• the patient was assessed as untreatable by surgery.
• patients received second-line or third-line chemotherapy and were treated with immunodetector point inhibitors.
• the patient had complete preliminary pathological information, tumor site, pathological type and other information.
• the patient must have adequate tumor tissue or 5-10 FFPE white tablets to provide; After treatment, patients were returned to the hospital for re-examination every 3 treatment cycles, and plasma and peripheral blood samples could be obtained during the whole process.
• other indicators of the patients met the general clinical trial enrollment conditions.
• subjects read and fully understand the instructions to patients, and sign the informed consent.

You may not qualify if:

• blood samples cannot be obtained before treatment.
• the patient has clear infection status.
• the patient has other serious diseases besides esophageal cancer.
• (5) current patients with alcoholism or drug abuse. (6) pregnant female patients. (7) the patient has a clear history of neurological or mental disorders.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal 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: August 29, 2019
• First Posted: August 30, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2021
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

CN (1)