Back to resultsA Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer
Primary Purpose
Cervical Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
QL1706
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer
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.
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
QL1706 injection
Arm Description
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
Outcomes
Primary Outcome Measures
The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)
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
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
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
The PFS assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1
Overall survival
Overall survival
Full Information
NCT ID
NCT05557565
First Posted
September 20, 2022
Last Updated
September 23, 2022
Sponsor
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05557565
Brief Title
A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer
Official Title
A Single-arm, Open, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Recurrent or Metastatic Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QL1706 injection
Arm Type
Experimental
Arm Description
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
QL1706
Intervention Description
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
Primary Outcome Measure Information:
Title
The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)
Description
The ORR assessed by the Independent Image Review Board (IRC) according to RECIST V1.1
Time Frame
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
Secondary Outcome Measure Information:
Title
The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1
Description
The ORR assessed by the investigator according to RECIST V1.1
Time Frame
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
Title
The Disease Control Rate (DOR) assessed by the Independent Image Review Board (IRC) and the investigator
Description
The DOR assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1
Time Frame
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
Title
The Progression-free survival (PFS) assessed by the Independent Image Review Board (IRC) and the investigator
Description
The PFS assessed by the Independent Image Review Board (IRC) and the investigator according to RECIST V1.1
Time Frame
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.
Title
Overall survival
Description
Overall survival
Time Frame
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peizhen Wang, bachelor
Phone
18001246877
Email
peizhen.wang@qilu-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Doctor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Doctor
Phone
13826299236
Email
LiuJH@sysucc.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer
We'll reach out to this number within 24 hrs