A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer

A Single-arm, Open, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Recurrent or Metastatic Cervical Cancer

This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.

This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer who have failed at least first-line platinum-containing standard therapy.

The study was divided into screening period/baseline, treatment period, and post-treatment follow-up period. Efficacy evaluation and safety monitoring should be performed throughout the study.

Inclusion Criteria:

• The subject will participate voluntarily and sign the informed consent form.
• Female, aged ≥18 years when signing the informed consent form.
• Recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy.
• At least one measurable lesion is needed.
• The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
• Adequate reserves of organ function is needed.

Exclusion Criteria:

• Active autoimmune disease.
• Central nervous system (CNS) metastasis.
• Concomitant diseases such as cardiovascular and cerebrovascular diseases.
• Fistula of female genital tract.
• Diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment.
• Previous recipients of immune checkpoint inhibitors.
• Received systemic antitumor drugs such as chemotherapy and targeted therapy within 4 weeks before the first use of the experimental drug; Received proprietary Chinese medicine with anti-tumor indications within 2 weeks before the first use of the experimental drug.
• Received radical concurrent chemoradiotherapy or adjuvant chemoradiotherapy within 12 weeks before the first use of the investigational drug; Received palliative radiotherapy (e.g., reductive radiotherapy for pain or bleeding) or other local treatments (e.g., radiofrequency ablation, transarterial chemoembolization, etc.) within 2 weeks before the first use of the investigational drug.
• History of immunodeficiency.
• History of allogeneic hematopoietic stem cell transplantation or organ transplantation.