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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Criteria

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.