A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QL1706 injection The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion |
Drug: QL1706
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
|
Outcome Measures
Primary Outcome Measures
- The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC) [Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years]
The ORR assessed by the Independent Image Review Board (IRC) according to RECIST V1.1
Secondary Outcome Measures
- The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1 [Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years]
The ORR assessed by the investigator according to RECIST V1.1
- The Disease Control Rate (DOR) assessed by the Independent Image Review Board (IRC) and the investigator [Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years]
The DOR assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1
- The Progression-free survival (PFS) assessed by the Independent Image Review Board (IRC) and the investigator [From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last QL1706 injection has been administered.]
The PFS assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1
- Overall survival [From date of enrollment until the date of death from any cause or date of lost to visit, assessed up to 2 years after the last QL1706 injection has been administered.]
Overall survival
Eligibility Criteria
Criteria
Inclusion Criteria:
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The subject will participate voluntarily and sign the informed consent form.
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Female, aged ≥18 years when signing the informed consent form.
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Recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy.
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At least one measurable lesion is needed.
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The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1.
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Adequate reserves of organ function is needed.
Exclusion Criteria:
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Active autoimmune disease.
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Central nervous system (CNS) metastasis.
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Concomitant diseases such as cardiovascular and cerebrovascular diseases.
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Fistula of female genital tract.
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Diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment.
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Previous recipients of immune checkpoint inhibitors.
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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.
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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.
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History of immunodeficiency.
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History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Jihong Liu, Doctor, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QL1706-206