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New treatment option for LOCALLY ADVANCED CERVICAL CANCERS
Official title Iparomlimab/Tuvonralimab Injection Plus CCRT in LACC
ClinicalTrials.gov ID: NCT07232654
What this study is testing
What is Iparomlimab/Tuvonralimab?
Iparomlimab/Tuvonralimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced cervical cancers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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...
- Willingness to comply with the study procedures before study entry Main
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.