Phase
Condition
Cervical Cancer
Uterine Disorders
Treatment
Iparomlimab/Tuvonralimab
Brachytherapy and External Beam Radiotherapy
Cisplatin
Clinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria
Informed consent.
Female patients aged ≥18 years and ≤ 75 years at time of inform consent signature
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Expected survival ≥ 3 months
Patients must have histologically confirmed diagnosis of HPV-related cervicalsquamous, or adenocarcinoma, or adenosquamous carcinoma
FIGO 2018 stage T3a-4a (III-IVA), N1 (positive lymph node metastasis on CT/MRI withshort-axis ≥1 cm, or PET-CT showing one or more lymph node metastases with SUVmax ≥2.5), M0
Has at least one evaluable disease per RECIST 1.1
Has adequate organ function
Hematology: ANC ≥1.5 ×10⁹/L; platelets ≥100 ×10⁹/L; hemoglobin ≥90 g/L (noblood transfusion or growth factor support within 7 days)
Renal: CrCl ≥50 mL/min (Cockcroft-Gault formula), urine protein <2+ or 24h <1.0g
Hepatic: Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN
Coagulation: INR and APTT ≤1.5×ULN
Cardiac: LVEF ≥50%
Women of childbearing potential: a negative urine or serum pregnancy test within 3days prior to the first dose of study drug (if the urine pregnancy test resultcannot be confirmed as negative, a serum pregnancy test must be performed, and theserum result will be considered definitive).If a female participant of childbearingpotential engages in sexual activity with a male partner who is not surgicallysterile, she must use an acceptable method of contraception starting from screeningand agree to continue using the same contraception for 120 days after the last doseof study drug. Whether to discontinue contraception after this period should bediscussed with the investigator
Willingness to comply with the study procedures before study entry
Exclusion
Main Exclusion Criteria:
Cervical cancer of other histology (e.g., neuroendocrine carcinoma, sarcoma)
Evidence of distant metastasis
Prior total hysterectomy (subtotal or cervical-sparing surgery allowed)
Unable or unwilling to receive brachytherapy
Prior treatment with immune checkpoint inhibitors or other tumor immunotherapy
Systemic corticosteroid (>10 mg/day prednisone or equivalent) or immunosuppressivetherapy within 2 weeks (exceptions: inhaled/topical ≤10 mg/day, physiologicreplacement ≤10 mg/day, premedication for hypersensitivity).
Immunomodulatory drugs within 2 weeks (e.g., thymosin, interferons, IL-2)
Study Design
Connect with a study center
National Cancer Center/Cancer Hospital
Beijing 1816670,
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.