Last updated: July 26, 2022
Sponsor: Qilu Pharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting
Phase
2
Condition
Vaginal Cancer
Cervical Cancer
Pelvic Cancer
Treatment
N/AClinical Study ID
NCT05179317
QL1706-204
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years at the time of study entry.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- At least one measurable lesion (according to RECIST v1.1)
- Cervical squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinomadiagnosed by histopathology and confirmed by imaging as recurrent or stage ⅣB cervicalcancer.
- No brain metastasis, or no meningeal metastasis.
- Patients must have normal function as defined:
- Any unresolved AEs ≤ CTCAE Grade 1 (except alopecia).
- Negative pregnancy test for females of child-bearing potentials.
- Patients with reproductive function agreed to take effective contraceptive measuresduring the treatment and in 6 months after the end of administration.
- Patients must be able to understand and volunteer to sign the informed consent.
Exclusion
Exclusion Criteria:
- Has received prior chemoradiotherapy within 3 months before enrollment,or has receivedprior radiotherapy within 2 weaks before enrollment.
- Is currently participating in or has participated in a study of an investigationalagent within 4 weeks before enrollment.
- Has any active autoimmune diseases or a history of autoimmune diseases (such as thefollowing, but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis,pituitary inflammation, vasculitis, nephritis, thyroid hyperfunction; patients withvitiligo; complete remission of asthma in childhood, can be included without anyintervention after adulthood; asthma patients who require bronchodilators for medicalintervention cannot be included).
- Is using immunosuppressive agents or systemic hormonal therapy to achieveimmunosuppressive purposes (agents amount > 10 mg / day of prednisone or othertherapeutic hormones), and continue to use within 2 weeks before enrollment.
- Known history of hypersensitivity to macromolecular protein preparation or anycomponents of the QL1604 formulation, or any components of the study drugs.
- Has uncontrolled clinically significant cardiac and cerebral vascular diseases within 6 months before enrollment, including but not limited to the following: myocardialinfarction, severe or unstable angina, coronary artery/peripheral artery bypassgrafting, congestive heart failure, cerebrovascular accident (including transientischemic attack).
- Symptomatic congestive heart failure (New York Heart Association Grade II-IV), orNCI-CTCAE v5.0 ≥ 2 arrhythmia, atrial fibrillation of any grade, or clinicallysignificant supraventricular arrhythmia or ventricular arrhythmia requirement fortreatment or intervention.
- Has active infection or an unexplained fever > 38.5°C during screening visits(subjects with tumor fever may be enrolled at the discretion of the investigator).
- Hepatitis b surface antigen (HBsAg) positive and/or hepatitis b core antibody (HBcAb)positive and HBVDNA>103copies/ml, hepatitis c virus antibody positive .
- Known history of human immunodeficiency virus (HIV) infection, or other acquired orcongenital immunodeficiency diseases,or has a history of organ transplantation (exceptcorneal transplantation).
- Has been vaccinated with live anti-tumor vaccine, or have received anti-tumorimmunotherapy, or may receive other systemic anti-tumor treatments during the studyperiod.
- Has a clear history of neurological or mental disorders, including epilepsy ordementia.
- Patients with other malignancies witnin 5 years( except cured basal cell carcinoma ofskin cancer, papillary thyroid carcinoma).
Study Design
Total Participants: 60
Study Start date:
May 30, 2021
Estimated Completion Date:
December 31, 2023
Connect with a study center
Liaoning Cancer Hospital
Shenyang, Liaoning 110000
ChinaSite Not Available
Shandong Cancer Hospital
Jinan, Shangdong 250000
ChinaSite Not Available

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