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NCT Number: NCT07232654

Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center/Cancer Hospital

Beijing, China

Location status: Recruiting

Location contact

Iparomlimab/Tuvonralimab injection plus CCRT in LACC

CONTACT

[email protected]

010-67781331

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

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 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)

Treatment and study plan

Iparomlimab/Tuvonralimab

Drug

IV infusion

Cisplatin

Drug

IV infusion

Brachytherapy and External Beam Radiotherapy

Radiation

Radiation

Primary outcomes

  1. 2-year PFS rate

    Time frame: up to 24 months

Secondary outcomes

  1. ORR

    Time frame: Up to approximately 24 months

  2. PFS

    Time frame: Up to approximately 24 months

  3. DCR

    Time frame: Up to approximately 24 months

  4. DoR

    Time frame: Up to approximately 24 months

  5. OS

    Time frame: Up to approximately 36 months

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 18, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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