Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Inject… (NCT06455046) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of AK104 Combined With Chemotherapy and Recombinant Human Adenovirus 5 Injection in Cervical Cancer
China37 participantsStarted 2023-10-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion Criteria:
\- 1）Enrollees in this study will be voluntary participants who sign a written informed consent form and are capable of adhering to scheduled visits and related procedures.2) Ages between 18 and 75 years old.3) Histologically or cytologically confirmed cases of persistent, recurrent, or metastatic cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Note: A pathological report is necessary for confirmation of the original primary tumor histology.4) Must have experienced failure with at least one standard systemic treatment and documented disease progression: Failure is defined as progression or recurrence within six months after at least one cycle of standard systemic treatment. Patients who have developed immune acquired resistance may also be included if they experienced PD after achieving CR or PR with anti-PD-1/PD-L1 antibody treatment, or PD after experiencing SD≥6 months with anti-PD-1/PD-L1 antibody treatment.
5\) Not suitable for local treatments such as unresectable surgery and/or definitive concurrent radiotherapy and chemotherapy.6) The interval between the end of previous systemic treatment and the first dose of the study drug must be ≥2 weeks. Additionally, any treatment-related adverse events must have recovered to a grade ≤1 according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 (excluding hair loss and fatigue).7) At least one measurable target lesion must be present according to RECIST V1.1 crit…