A Phase 2 interventional study of RC48 + Tislelizumab in Cervical Cancer Recurrent, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 30 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Durg：RC48: intravenous drip, 2mg/kg, D1, repeated once every 2 weeks. Durg ：Tislelizumab: intravenous drip, fixed dose 600 mg, D1, repeated once every 6 weeks.
Drug: RC48 + Tislelizumab
RC48: intravenous drip, 2mg/kg, D1, repeated once every 2 weeks. Tislelizumab: intravenous drip, fixed dose 600 mg, D1, repeated once every 6 weeks.
Objective 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
Plan to share: Undecided
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Peking Union Medical College Hospital