Cervical Cancer
Conditions
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.
Interventions
DRUGQL1706
The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactPeizhen Wang, bachelor
Outcome results
None listed