RecruitingPhase 2NCT06063018

RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer

A Single-arm, Single Center, Phase II Study of RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer


Sponsor

Peking Union Medical College Hospital

Enrollment

30 participants

Start Date

Aug 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the combination of RC48 (an antibody-drug conjugate targeting HER2) and tislelizumab (an immunotherapy drug) as a second-line treatment for women with recurrent cervical cancer whose tumor expresses the HER2 protein. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have confirmed cervical cancer (squamous cell, adenocarcinoma, adenosquamous, or small cell type) - Your tumor expresses HER2 (confirmed by testing) - Your cancer has come back after prior treatment - Your general health is good (ECOG 0 or 1) and life expectancy is at least 6 months **You may NOT be eligible if...** - Your tumor does not express HER2 - You have already received more than one line of systemic treatment for recurrent disease - You have significant heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRC48 + 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.


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06063018


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