The primary objective of this study is to evaluate the efficacy and safety of Iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy for cervical cancer neoadjuvant therapy. Additionally, the study aims to identify potential predictive biomarkers for therapeutic efficacy by analyzing tumor tissues and peripheral blood samples from participants receiving this combined treatment regimen.
Voluntary signing of written Informed Consent Form (ICF).
Age ≥18 years and ≤75 years at enrollment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically or cytologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma) with clinical staging by FIGO 2018 criteria: IB3, IIA2, IIB, or IIIC (parametrial invasion without reaching the pelvic wall, no vaginal lower third involvement).
Histopathological type other than cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (e.g., small cell carcinoma, clear cell carcinoma, sarcoma).
History of other malignancies within 3 years prior to enrollment, excluding localized malignancies cured by local therapy (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, or ductal carcinoma in situ of the breast).
Simultaneous enrollment in another clinical study, unless it is an observational, non-interventional study or within the follow-up period of an interventional study.
Non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor) within 2 weeks prior to first dose; herbal or proprietary Chinese medicine with antitumor indications within 1 week prior to first dose.
Single group
Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy
DrugIparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy
CR/PR rate (%) in subjects with ≥1 response event
The ORR assessment will include data obtained before surgery or until disease progression (whichever occurs first), or until the last evaluable assessment data before surgery if no disease progression has occurred.
pCR rate (%) post neoadjuvant therapy
The proportion of patients with no residual tumor cells in the tumor tissue specimens obtained through surgical resection after neoadjuvant therapy.
Time to first event post-neoadjuvant therapy
The time from the start of neoadjuvant therapy to the occurrence of any of the following events for the patient: disease progression, local or distant recurrence diagnosed by imaging or biopsy, death due to any cause, etc.
Patients whose residual active tumor cells are ≤ 10% after neoadjuvant therapy
MPR（Major Pathological Response） rate = (Number of subjects achieving MPR / Total number of subjects) × 100%.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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