A Study of QL1706 Combined with Nine HPV Vaccine As First-line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer

Launched by NORTHERN JIANGSU PEOPLE'S HOSPITAL · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for women with advanced cervical cancer (Stage IVB) that has come back or spread, using a combination of a drug called QL1706 and a nine-valent HPV vaccine. The treatment involves receiving QL1706 through an intravenous infusion (a method of delivering medicine directly into the bloodstream) once every three weeks for up to two years, or until the doctor or patient decides to stop for any reason. The HPV vaccine is given in three doses, with the first dose given just before the first infusion of QL1706.

To participate in this trial, women must have been diagnosed with cervical cancer and have at least one measurable tumor that hasn't been treated with radiation before. They should also be in reasonably good health, able to follow the study's requirements, and have a life expectancy of at least 12 weeks. Participants will be monitored closely for side effects and overall health throughout the study. It's important that candidates can commit to the trial and understand all aspects of the study before agreeing to take part.

Gender

FEMALE

Eligibility criteria

• • 1. Patients with unsystematically treated cervical cancer, who voluntarily participate in the clinical study; fully understand and informed about the study and sign the Informed Consent Form (ICF); willing to follow and have the ability to complete all the trial procedures.
• • 2. With histologically confirmed diagnosis of cervical cancer, a pathology report and pathology slides are required.
• • 3. have at least one measurable lesion as assessed by the investigator according to RECIST 1.1.
• • Note: Measurable target lesions cannot be selected from previous radiotherapy sites. If the target lesion at the site of prior radiotherapy is the only optional target lesion, the investigator is required to provide anterior and posterior imaging data showing significant progression of this lesion.
• • 4. Recovery of AE associated with prior antitumor therapy to CTCAE ≤ Grade 1 (except for Grade 2 alopecia).
• • 5. ECOG score ≤ 1 within 7 days prior to first dose of study drug.
• • 6. expected survival ≥ 12 weeks.
• • 7. Subjects with chronic HBV infection must have HBV-DNA \< 1000 copies/ml and must agree to receive antiviral therapy according to treatment guidelines for patients with hepatitis B surface antigen positivity; patients with HCV-RNA positivity must agree to receive antiviral therapy according to treatment guidelines and have liver function at CTCAE ≤ grade 1.
• • 8. Normal major organ function, i.e., the following criteria are met (no transfusion, erythropoietin, or colony-stimulating factor (G-CSF) therapy within 14 days prior to administration of study drug) Hematologic Neutrophils (ANC) ≥ 1.5 x 109/L Platelets (PLT) ≥ 90×109/L Hemoglobin (Hb) ≥ 90g/L Liver Function Total bilirubin (TBIL) ≤ 1.5 x upper limit of normal (ULN) Glutamate aminotransferase (ALT) ≤ 2.5×ULN; For patients with liver metastases ≤ 5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN; For patients with liver metastases ≤ 5×ULN Renal Function Creatinine (Cr) ≤ 1.5×ULN; If \> 1.5 x ULN, creatinine clearance ≥ 50 ml/min. (calculated according to the Cockcroft-Gault formula) Coagulation Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN Prothrombin time (PT) ≤ 1.5×ULN International normalized ratio (INR) ≤ 1.5×ULN
• • 9. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study drug and be willing to use a hi ghly effective method of contraception for the duration of the trial and for 90 days after the last administration of the test drug.