Spots Global Cancer Trial Database for Disitamab Vedotin Combined With Tislelizumab in Advanced HER2 Positive Colorectal Cancer
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Trial Identification
Brief Title: Disitamab Vedotin Combined With Tislelizumab in Advanced HER2 Positive Colorectal Cancer
Official Title: A Single Arm, Open Label, Multiple Center, Prospective Study of Disitamab Vedotin Combined With Tislelizumab in HER2 Positive Advanced Colorectal Cancer Failed at Least Two Lines of Systemic Treatment.
Study ID: NCT05493683
Conditions
Study Description
Brief Summary: Among patients with colonrectal cancer, 5% were HER-2 positive, but the immunohistochemical results were mostly HER-2 2 +, which did not meet the indications of HER-2 targeting drugs. Disitamab Vedotin , which was listed in China last year, achieved similar results in HER-2 2+ and 3+, according to a clinical trial for breast cancer, suggesting that patients with colonrectal cancer may benefit from it. Tislelizumab is a PD-1 monoclonal antibody, which has been approved for a variety of tumors. It was reported that anti-HER-2 treatment can improve the tumor immune microenvironment and improve the efficacy of immunotherapy. At the same time, our previous studies showed that anti-PD-1 combined with Disitamab Vedotin can significantly inhibit the growth of colon tumor in mice. Therefore, Disitamab Vedotin and Tislelizumab were used in this study. This prospective clinical trial may bring new hope for the treatment of HER-2 positive CRC patients.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Changzhou NO.2 People's Hospital, Changzhou, Jiangsu, China
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huai'an, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu, China
the Third Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Xuzhou Central Hospital, Xuzhou, Jiangsu, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
Name: Gu Yanhong
Affiliation: The First Affiliated Hospital with Nanjing Medical University
Role: PRINCIPAL_INVESTIGATOR
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