There is currently no standardized treatment for patients who have undergone first-line standard treatment. In this study, We investigated the efficacy and safty of RC48 combined with Tislelizumab in the second-line treatment of patients with HER2 expression in recurrent cervical cancer.
This study is a single-arm, single center II study，aim to evaluate the effective and safe of RC48 combined with Tislelizumab in the second-line treatment of patients with HER2 expression in recurrent cervical cancer. This study set up a safety introduction period, that is, the first 6 subjects enrolled in the study will be slowly monitored for safety. The monitoring time window was 28 days after first receiving the study drug. If Dose limit toxicity (DLT) is observed in ≥2 of the first 6 subjects and is assessed by the investigator team to be related to RC48 therapy, the initial dose of RC48 therapy in subsequent enrolled patients is adjusted to 1.5 mg/kg Q2W. During the safety induction period, if a subject does not complete the safety assessment for the tolerability observation period (within 28 days after the first dose) for reasons other than dose tolerance, a new subject will be replaced. After the safety introduction period, any enrolled subjects who withdraw early from the trial will not be allowed to be replaced by additional enrolled subjects. The number corresponding to the subject is not allowed to be reused by other new subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
RC48: intravenous drip, 2mg/kg, D1, repeated once every 2 weeks. Tislelizumab: intravenous drip, fixed dose 600 mg, D1, repeated once every 6 weeks.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective Response Rate（ORR）
Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Overall Survival(OS)
The time from the start of treatment with this study protocol to the time of all-cause death of patients.
Time frame: up to 3 years
Progression-free survival(PFS)
Time from initiation of study protocol treatment to disease progression (if occurring within 30 days of end of treatment) or death, as assessed by clinician or with or without radiographic progression.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Disease Control Rate (DCR)
Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Duration of response（DOR）
The time between the onset of efficacy and confirmation of tumor progression
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
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