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The primary objective of this study is to evaluate the efficacy and safety of Iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy for cervical cancer neoadjuvant therapy. Additionally, the study aims to identify potential predictive biomarkers for therapeutic efficacy by analyzing tumor tissues and peripheral blood samples from participants receiving this combined treatment regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Evaluation of the Efficacy of Iparomlimab and Tuvonralimab in Combination with Platinum-Based Chemotherapy for Neoadjuvant Therapy of Cervical Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy | Drug | Iparomlimab and tuvonralimab (QL1706) combined with platinum-based chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| CR/PR rate (%) in subjects with ≥1 response event | The ORR assessment will include data obtained before surgery or until disease progression (whichever occurs first), or until the last evaluable assessment data before surgery if no disease progression has occurred. | 4 months after the patient was enrolled in the study |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate (%) post neoadjuvant therapy | The proportion of patients with no residual tumor cells in the tumor tissue specimens obtained through surgical resection after neoadjuvant therapy. | 6 months after the patient was enrolled in the study |
| Time to first event post-neoadjuvant therapy |
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Inclusion Criteria:
Agreement to undergo radical hysterectomy with no surgical contraindications as judged by the investigator.
At least one untreated measurable lesion according to RECIST v1.1.
Consent to provide tumor tissue and peripheral blood samples during the screening period and study procedures for related research.
Adequate organ function:
a) Hematology (no blood components or growth factor support within 7 days before study treatment): i. Absolute neutrophil count (ANC) ≥1.5×10⁹/L (1,500/mm³); ii. Platelet count ≥100×10⁹/L (100,000/mm³); iii. Hemoglobin ≥90 g/L. b) Renal: i. Calculated creatinine clearance (CrCl) ≥50 mL/min (Cockcroft-Gault formula); ii. Urine protein <2+ or 24-hour urine protein <1.0 g. c) Hepatic: i. Total bilirubin (TBil) ≤1.5×ULN; ii. AST and ALT ≤2.5×ULN; iii. Albumin (ALB) ≥28 g/L. d) Coagulation: i. INR and APTT ≤1.5×ULN (stable anticoagulation therapy allowed if parameters remain within therapeutic range).
e) Cardiac: i. Left ventricular ejection fraction (LVEF) ≥50%.
Fertile women must have a negative urine or serum pregnancy test within 3 days before first dose. If urine test is inconclusive, serum testing is required. Contraception must be used from screening until 120 days post-treatment. Barrier methods or hormonal contraceptives (e.g., pills) are required.
Willingness and ability to comply with scheduled visits, protocols, labs, and study requirements.
Expected survival ≥6 months.
Exclusion Criteria:
History of immunodeficiency, HIV seropositivity, or current long-term systemic corticosteroid/immunosuppressant use.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li | Contact | 011+86+15553115531 | drldp@126.com |
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The time from the start of neoadjuvant therapy to the occurrence of any of the following events for the patient: disease progression, local or distant recurrence diagnosed by imaging or biopsy, death due to any cause, etc. |
| 2 years after the patient was enrolled in the study |
| Patients whose residual active tumor cells are ≤ 10% after neoadjuvant therapy | MPR(Major Pathological Response) rate = (Number of subjects achieving MPR / Total number of subjects) × 100%. | 6 months after the patient was enrolled in the study |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 2 years after the patient was enrolled in the study |
| Surgical Delay Rate (%) | rate = delayed cases / total cases × 100% | 6 months after the patient was enrolled in the study |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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