Iparomlimab and Tuvonralimab Combined With Platinum-Based Chemotherapy for Neoadjuvant Treatment of Cervical Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShandong Tumor Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy

Treatment groups

28 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators