A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer
NCT ID: NCT05557565
Last Updated: 2022-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2021-12-21
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QL1706 injection
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
QL1706
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
Interventions
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QL1706
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jihong Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QL1706-206
Identifier Type: -
Identifier Source: org_study_id
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