Liquid Biopsy in Monitoring the Neoadjuvant Chemotherapy and Operation in Gastric Cancer

NCT03957564 | Unknown Phase 2

• 1 other identifier: AHQU-2019002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the clinical value of dynamic detection of circulating tumor cells(CTCs), circulating tumor DNA(ctDNA) and cell-free DNA(cfDNA) in neoadjuvant chemotherapy and operation of resectable or locally advanced gastric or gastro-oesophageal junction cancer.

Conditions

Gastric Cancer; Gastro-oesophageal Junction Cancer

Keywords

Gastric cancer; Gastro-oesophageal junction cancer; Neoadjuvant chemotherapy; Radical gastrectomy; Circulating tumor cells; Circulating tumor DNA; Circulating cell free DNA

Outcome Measures

Primary Outcomes (6)

• Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.

  Numbers of CTC pre- and post- neoadjuvant chemotherapy and after operation.

  2 years

• Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.

  Types of CTC pre- and post- neoadjuvant chemotherapy and after operation.

  2 years

• Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.

  Mutation rate of ctDNA pre- and post- neoadjuvant chemotherapy and after operation.

  2 years

• Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation.

  Concentration of cfDNA pre- and post- neoadjuvant chemotherapy and after operation.

  2 years

• The relationship between tumor response and changes in numbers of CTC pre- and post-neoadjuvant chemotherapy and after operation.

  The relationship between tumor response and changes in numbers of CTC pre- and post-neoadjuvant chemotherapy and after operation.

  2 years

• The relationship between tumor response and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and after operation.

  The relationship between tumor response and mutation of ctDNA pre- and post-neoadjuvant chemotherapy and after operation.

  2 years

Secondary Outcomes (3)

• Disease Free Survival(DFS)

  2 years

• Overall survival(OS)

  2 years

• Types of tumor-associated DNA in tumor tissues after operation.

  2 years

Study Arms (1)

Patients receiving neoadjuvant chemotherapy.

EXPERIMENTAL

1. Compare the monitoring of CTC, ctDNA and cfDNA with the results of CT scan and the blood level of CEA ,CA19-9 and CA72-4 tumor markers to explore the clinical value of dynamic detection of CTC, ctDNA and cfDNA in neoadjuvant chemotherapy and operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. 2. Explore the clinical value of different types of CTC in neoadjuvant chemotherapy and Operation for locally advanced or resectable gastric or gastro-oesophageal junction cancer. CTC can be classified into three types: epithelial CTC, mesenchymal CTC, hybrids CTC. 3. Explore the consistency between plasma ctDNA and tumor related DNA in pathological tissues after operation. 4. To explore the relationship between the dynamic changes of plasma CTC, ctDNA and cfDNA levels and the prognosis of patients after operation.

Drug: Neoadjuvant chemotherapy with PSOX regimen.; Other: Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma.; Other: Detect the tumor related DNA in pathological tissues after operation.; Other: Follow-up of DFS and OS in patients with gastric cancer after operation.

Interventions

Neoadjuvant chemotherapy with PSOX regimen. DRUG

Resectable gastric or gastro-oesophageal junction cancer patients receiving neoadjuvant chemotherapy with PSOX（Paclitaxel+Oxaliplatin+S1）regimen. The details are as follows: Paclitaxel 135mg/m2 d1, Oxaliplatin 85mg/m2 d1, S1 40-60mg/m2 twice daily, d1-14 , 21 days is one cycle.

Patients receiving neoadjuvant chemotherapy.

Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma. OTHER

Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in 3 time points：Before neoadjuvant chemotherapy, After 2-3 cycles of neoadjuvant chemotherapy, 10 days after operation.

Patients receiving neoadjuvant chemotherapy.

Detect the tumor related DNA in pathological tissues after operation. OTHER

Detect the tumor related DNA in pathological tissues after operation.

Patients receiving neoadjuvant chemotherapy.

Follow-up of DFS and OS in patients with gastric cancer after operation. OTHER

Follow-up of DFS and OS in patients with locally advanced or resectable gastric or gastro-oesophageal Junction cancer.

Patients receiving neoadjuvant chemotherapy.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with resectable or locally advanced gastric or gastro-oesophageal junction cancer(\>T1 and N+) without distant metastases (M0).
• Pathological examination confirmed gastric or gastro-oesophageal junction cancer (adenocarcinoma, signet ring cell carcinoma, mucinous adenocarcinoma, squamous cell carcinoma, regardless of the degree of tissue differentiation).
• Ambulatory males or females, age ≥ 18 years.
• Karnofsky Performance Score (KPS) ≥70 or ECOG(Eastern Cooperative Oncology Group) performance status: 0 or 1.
• Patients who can tolerate PSOX neoadjuvant chemotherapy.
• Planning to undergo radical gastrectomy after neoadjuvant chemotherapy.
• With cancer lesions that can be measured according to RECIST 1.1 criteria.
• No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy.
• Adequate organ function as defined below: Hemoglobin ≥ 9 g/dl, Absolute neutrophil count(ANC） ≥ 1.5×109/L, Platelets ≥ 100\*109/L, Alkaline phosphatase( ALP) ≤ 2.5×ULN,Total bilirubin（TBIL）≤ 1.5×ULN(upper limit of normal), Renal Serum Creatinine \< 1.5 ULN, Serum Albumin ≥ 30g/l.

You may not qualify if:

• Female in pregnancy or lactation, or refuse to receive contraception measures during chemotherapy.
• With distant metastasis or peritoneal dissemination diagnosed by CT/EUS(endoscopic ultrasonography).
• Underwent prior antitumor treatment, including chemotherapy, radiotherapy, immune therapy or target therapy.
• Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease or condition that would make the subject inappropriate for study participation.
• Clinically serious cardiac disease or pulmonary dysfunction.
• Refuse to provide blood/tissue sample.
• Other situation to be judged not adaptive to the study by investigators.

Sponsors & Collaborators

• Affiliated Hospital of Qinghai University: lead

Study Sites (1)

Jiuda Zhao

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Neoplastic Cells, Circulating

Interventions

Neoadjuvant Therapy; Circulating Tumor DNA; Cell-Free Nucleic Acids; CA-19-9 Antigen; CA-72-4 antigen

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; DNA, Neoplasm; DNA; Antigens, Tumor-Associated, Carbohydrate; Antigens, Neoplasm; Antigens; Biological Factors; Lewis Blood Group Antigens; Blood Group Antigens; Antigens, Surface; Epitopes; Isoantigens; Biomarkers, Tumor; Biomarkers

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 21, 2019
• Study Start: May 28, 2019
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2024
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

CN (1)