RecruitingPhase 2NCT06455046

Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer

Efficacy and Safety of AK104 Combined With Pemetrexed, Carboplatin and Recombinant Human Adenovirus 5 Injection in Advanced Recurrent Cervical Cancer: a Multicenter, Single-arm, Prospective Phase II Clinical Study

Sponsor

Fujian Cancer Hospital

Enrollment

37 participants

Start Date

Oct 11, 2023

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer Recurrent

Summary

In order to improve the clinical effect and find a new safe and effective treatment model for advanced recurrent cervical cancer, this study explored the efficacy level safety of pemetrexed, carboplatin, recombinant human adenovirus type 5, and AK104 regimen in recurrent and refractory advanced cervical cancer. For some patients with immune-resistant cervical cancer, combination chemotherapy and oncolytic virus therapy can promote the transformation of cold tumors into hot tumors, eliminate and then reverse the suppressor factors of immune resistance, and break the dilemma of immunotherapy drug resistance, which is a new method and strategy under immunotherapy drug resistance.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of AK104 (a dual checkpoint immunotherapy drug targeting both PD-1 and CTLA-4) with chemotherapy and an oncolytic adenovirus injection (a virus that infects and kills cancer cells) in patients with advanced cervical cancer that has not responded to prior treatments. **You may be eligible if...** - You are aged 18–75 with confirmed persistent, recurrent, or metastatic cervical cancer (squamous cell, adenocarcinoma, or adenosquamous type) - Your cancer has progressed after at least one prior standard treatment - You have at least one measurable tumor on imaging - You are in good health (ECOG 0 or 1) **You may NOT be eligible if...** - You have not tried any prior standard systemic treatment - Your cancer involves the central nervous system - You have uncontrolled infections, autoimmune disease, or severe organ dysfunction - You are pregnant or breastfeeding 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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