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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
2.0mg/kg,q2w
400mg,q6w
Changzhou NO.2 People's Hospital
Changzhou, Jiangsu, China
RECRUITINGThe Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huai'an, Jiangsu, China
RECRUITINGThe First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGthe Third Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGXuzhou Central Hospital
Xuzhou, Jiangsu, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate(ORR)
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
Time frame: up to 2 years
Progression-free Survival(PFS)
PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.
Time frame: From date of subjects until the date of first documented progression or death from any cause, whichever came first, assessed up to 24 months
Overall Survival (OS)
OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time frame: From assignment of the first subject until 32 death events observed, up to 2 years.
Disease control rate (DCR)
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD).
Time frame: up to 2 years
Safety and Feasibility
Safety is defined as the incidence of Grade 3-4 Treatment-Related Adverse Events (TRAEs) from the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.
Time frame: up to 2 years
Duration of Response (DOR)
DOR is defined as the time from randomization to disease progression or death in patients who achieve complete or partial response.
Time frame: up to 2 years
Shiyun Cui, Dr
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