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Trial Title:
A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer
NCT ID:
NCT05557565
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QL1706
Description:
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by
intravenous infusion
Arm group label:
QL1706 injection
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.
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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Jihong Liu, Doctor
Phone:
13826299236
Email:
LiuJH@sysucc.org.cn
Start date:
December 21, 2021
Completion date:
June 30, 2023
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557565
