Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-11-11
2028-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Participants will receive 1 cycle of Iparomlimab/Tuvonralimab induction therapy followed by concurrent chemotherapy and radiotherapy. Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.
Iparomlimab/Tuvonralimab
IV infusion
Cisplatin
IV infusion
Brachytherapy and External Beam Radiotherapy
Radiation
Arm 2
Participants will receive Iparomlimab/Tuvonralimab combined with concurrent chemotherapy and radiotherapy.
Iparomlimab/Tuvonralimab will be administered by intravenous infusion at a dose of 5 mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator or withdraw consent or have completed 2 years of Iparomlimab/Tuvonralimab treatment.
Iparomlimab/Tuvonralimab
IV infusion
Cisplatin
IV infusion
Brachytherapy and External Beam Radiotherapy
Radiation
Interventions
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Iparomlimab/Tuvonralimab
IV infusion
Cisplatin
IV infusion
Brachytherapy and External Beam Radiotherapy
Radiation
Eligibility Criteria
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Inclusion Criteria
* 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 cervical squamous, or adenocarcinoma, or adenosquamous carcinoma
* FIGO 2018 stage T3a-4a (III-IVA), N1 (positive lymph node metastasis on CT/MRI with short-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 (no blood transfusion or growth factor support within 7 days)
* Renal: CrCl ≥50 mL/min (Cockcroft-Gault formula), urine protein \<2+ or 24h \<1.0 g
* 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 3 days prior to the first dose of study drug (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test must be performed, and the serum result will be considered definitive).If a female participant of childbearing potential engages in sexual activity with a male partner who is not surgically sterile, she must use an acceptable method of contraception starting from screening and agree to continue using the same contraception for 120 days after the last dose of study drug. Whether to discontinue contraception after this period should be discussed with the investigator
* Willingness to comply with the study procedures before study entry
Exclusion Criteria
* 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 immunosuppressive therapy within 2 weeks (exceptions: inhaled/topical ≤10 mg/day, physiologic replacement ≤10 mg/day, premedication for hypersensitivity).
* Immunomodulatory drugs within 2 weeks (e.g., thymosin, interferons, IL-2)
18 Years
75 Years
FEMALE
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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LING YING WU
Professor
Locations
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National Cancer Center/Cancer Hospital
Beijing, , China
Countries
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Facility Contacts
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Other Identifiers
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QLMA-IIT-CC-001
Identifier Type: -
Identifier Source: org_study_id
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