LOCALLY ADVANCED CERVICAL CANCERS
Conditions
Keywords
QL1706, Concurrent Chemoradiation Therapy, Cervical cancer
Brief 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.
Interventions
IV infusion
DRUGCisplatin
IV infusion
Radiation
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year PFS rate | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| ORR | Up to approximately 24 months |
| PFS | Up to approximately 24 months |
| DCR | Up to approximately 24 months |
| DoR | Up to approximately 24 months |
| OS | Up to approximately 36 months |
Countries
China
Outcome results
None listed