Cervical cancer
Conditions
Interventions
Experimental group:QL1706 Combined Chemotherapy
Sponsors
Hunan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the group and sign a written informed consent form; 2. Age 18-70 years; 3. Evaluated according to FIGO 2018 as: stage IB3, IIA2, or stage >=IIB/IIIC1r (evaluated by combined MRI or CT) locally advanced cervical adenocarcinoma, adenosquamous carcinoma, or squamous cell carcinoma; 4. Have at least one evaluable lesion (according to RECIST 1.1 criteria); 5. Expected survival time >=6 months; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1; 7. Female patients of childbearing potential (i.e., not menopausal or surgically sterilized) must have a negative serum pregnancy test within 7 days prior to study drug administration; and must use reliable contraception during the study drug administration and for 60 days after the last dose; 8. No prior systemic tumor treatment; 9. Major organ function is normal, meeting the following criteria: (1) Left ventricular ejection fraction (LVEF) >=50%; (2) Hemoglobin >=9 g/dL; (3) Absolute neutrophil count (ANC) >=1.5 × 10^9/L; (4) Platelets >=100 × 10^9/L; (5) Total serum bilirubin =40 mL/min; 10. Willing and able to comply with trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with histological types of clear cell carcinoma or sarcoma, including mixed tumors containing any of the above histologies, or cervical tumors of histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 2. History of malignant tumors other than cervical cancer, except for the following two situations: (1) Patients who have received potentially curative treatment and show no evidence of the disease within 5 years; (2) Successfully treated cases of resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, and other carcinoma in situ; 3. Previous allogeneic stem cell transplantation, allogeneic bone marrow transplantation, or solid organ transplantation; 4. Previous treatment with immune checkpoint inhibitors, including but not limited to anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; previous treatment with other antibody-drug conjugates; 5. Previous systemic antitumor therapy (including traditional Chinese medicine with antitumor indications); 6. Patients whose previous treatment-related adverse events have not recovered to = 160 mmHg or diastolic >= 100 mmHg), severe respiratory depression and hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, severe viral infection and septic shock, severe diabetes, immune-related diseases, hematologic disorders, or major surgical history; 9. Active, known or suspected autoimmune diseases requiring systemic treatment, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, asthma requiring bronchodilator therapy; 10. Diseases requiring treatment with systemic corticosteroids (daily >10 mg prednisone or equivalent) or other immunosuppressive drugs (cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks before the first dose of study drug or during the study; 11. Known or suspected allergy to anti-PD-1, PD-L1, CTLA-4 drugs, history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to study drug excipients; 12. Other significant clinical or laboratory abnormalities that the investigator believes may affect safety evaluation, such as uncontrolled diabetes, chronic kidney disease, grade II or above peripheral neuropathy (CTCAE V5.0), thyroid dysfunction, etc.; 13. Severe infections in the active phase or not clinically controlled, or active infections, including: (1) HIV (HIV-1/2 antibody) positive; (2) Active hepatitis B (HBsAg positive or HBV DNA >
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-related adverse events (TRAEs) associated with neoadjuvant therapy;Surgical resection clearance rate;Pathological complete response (pCR) rate;Event-Free Survival (EFS);Incidence of surgical complications;Overall Survival (OS); | — |
Countries
China
Contacts
Public Contactxiaohui
Hunan Cancer Hospital
Outcome results
None listed