Evaluation of HER2-targeted Therapy for Gastric Cancer and Establishment and Verification of Monitoring System

NCT05165602 | Unknown DMC

• 1 other identifier: 68Ga-PET
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The positive rate of HER2 in Chinese patients with gastric cancer is about 12-13%. HER2 positive gastric cancer has strong invasion, high metastasis rate and poor prognosis. The effective rate of chemotherapy combined with anti-HER2 targeted therapy for HER2 positive advanced gastric cancer was 47%, and the median survival time was extended to 13.8 months. However, the status of HER2 in advanced gastric cancer has obvious temporal and spatial heterogeneity, and the heterogeneity of HER2 directly affects the outcome of anti-HER2 treatment. Therefore, compared with biopsy pathology, it is urgent to explore noninvasive, systemic and repeatable methods to evaluate HER2 status of systemic lesions. 68Ga-HER2 Affibody-BCH, a HER2 imaging agent, was independently prepared by the Department of nuclear medicine of our center. According to the results of preclinical studies, in patients with HER2 positive advanced gastric cancer, the imaging effect was the best 2 hours after intravenous injection of 68Ga-HER2 Affibody and there was no adverse reaction. 68Ga-HER2 Affibody PET/CT imaging can directly reflect the HER2 heterogeneity within the same lesion and between the primary and metastatic lesions. In order to solve the clinical problems, this study intends to further explore the imaging of 68Ga-HER2 Affibody-BCH in patients with advanced gastric cancer and the amplification of HER2 in the peripheral blood of this population, so as to overcome the heterogeneity of HER2, explore the potential beneficiaries of anti HER2 treatment, and provide the basis for the evaluation of anti-HER2 treatment efficacy.

Conditions

HER2 Positive Gastric Cancer

Keywords

HER2 positive gastric cancer; 68Ga-HER2-affibody PET / CT; 18F-FDG PET / CT

Outcome Measures

Primary Outcomes (1)

• the relationship between 68Ga SUVmax before treatment and the therapeutic effect will be assessed by SPSS26.0

  The 68Ga SUVmax lesion will be determined by nuclear medicine doctors, and the efficacy will be determined according to Resist1.1 by physicians.Then SPSS 26.0 will be used to analyze the relationship between the two.

  3 years

Secondary Outcomes (1)

• the relationship between the dynamic change of 68Ga SUVmax and the therapeutic effect will be assessed by SPSS26.0

  3 years

Eligibility Criteria

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

Study Population

Subjects with high HER2 expression in gastric / gastroesophageal junction adenocarcinoma

You may qualify if:

• unresectable or metastatic adenocarcinoma of the gastroesophageal junction confirmed by pathology and imaging;
• Subjects had measurable lesions according to recist1.1, or unmeasurable but evaluable lesions;
• HER2 (1 +) or HER2 (2 +) or HER2 (3 +) was found in primary or metastatic lesions;
• Age: over 18 years old;
• ECOG was 0-2;
• Voluntary participation and written informed consent;

You may not qualify if:

• The function of liver and kidney was abnormal;
• Cardiac insufficiency;
• Preparation of pregnant, pregnant and lactating women;
• Unable to lie on your back for 30 minutes;
• Those who refused to join the clinical study;
• Those who have no legal capacity or whose medical or ethical reasons affect the continuation of the research;
• Refuse to provide tissue or hematological samples. 9）Allergic to both of the contrast agents used in the study

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (14)

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Biospecimen

Retention: SAMPLES WITH DNA

8 ml of blood was collected for detection of HER2 copy number in peripheral blood.

Study Officials

• lin shen, Professor

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

Central Study Contacts

xiaotian Zhang, Professor

CONTACT

010-88196088; zhangxiaotianmed@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of gastrointestinal oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: December 21, 2021
• Study Start: January 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)