Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC

Last updated: November 24, 2025
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Cervical Cancer

Uterine Disorders

Treatment

Iparomlimab/Tuvonralimab

Brachytherapy and External Beam Radiotherapy

Cisplatin

Clinical Study ID

NCT07232654
QLMA-IIT-CC-001
  • Ages 18-75
  • Female

Study Summary

This study is a clinical study to evaluate the safety and efficacy of Iparomlimab/Tuvonralimab Injection (QL1706, a Bifunctional Mabpair Product of Anti-PD-1 and Anti-CTLA-4 Antibodies) in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer.

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

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Iparomlimab/Tuvonralimab
Phase: 2
Study Start date:
November 11, 2025
Estimated Completion Date:
February 28, 2028

Connect with a study center

  • National Cancer Center/Cancer Hospital

    Beijing 1816670,
    China

    Active - Recruiting

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