Actively Recruiting
QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-04-08
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, multicenter Phase II study evaluating the efficacy and safety of QL1706 combined with chemotherapy in patients with advanced recurrent or metastatic endometrial cancer who progressed after prior anti-PD-1/L1 therapy.
CONDITIONS
Official Title
QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recurrent or metastatic endometrial carcinoma confirmed by pathology or imaging
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Prior anti-PD-1/L1 monoclonal antibody therapy with progression-free survival of at least 6 months
- Last dose of prior anti-PD-1/L1 therapy given at least 5 half-lives before starting this treatment
- Prior anti-angiogenic therapy allowed with at least 5 half-lives washout before re-administration
- Failed 2 or fewer lines of prior systemic therapy (endocrine therapy not counted)
- All other anti-tumor therapies stopped at least 4 weeks before treatment; hormonal medications require 30-day washout
- Adequate organ function as shown by lab tests during screening
- Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before first dose
- Use effective contraception if sexually active with non-sterilized male partner from screening until 6 months after last dose
- Voluntarily sign informed consent and agree to comply with trial requirements
You will not qualify if you...
- Previous treatment with PD-1/CTLA-4 dual-target immunotherapy, immune checkpoint agonists, or immune cell therapy
- Discontinued anti-PD-1/PD-L1 therapy due to related toxicity
- Active or history of autoimmune disease (except resolved childhood asthma or vitiligo without intervention)
- Use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone equivalent) within 2 weeks before enrollment
- Known active tuberculosis or active syphilis infection
- History of allogeneic organ or hematopoietic stem cell transplantation
- Severe allergic reactions to monoclonal antibodies
- History or evidence of interstitial lung disease or active non-infectious pneumonitis
- History or presence of central nervous system metastases
- History of other cancers unless disease-free for at least 3 years (excluding non-melanoma skin cancer or cervical carcinoma in situ)
- Uncontrolled hypertension or hypertensive crisis
- Recent serious heart conditions within 6 months
- Current thrombolytic or anticoagulant therapy (except low-dose aspirin or low molecular weight heparin)
- Recent arterial or venous thrombotic events within 6 months
- Major vascular disease within 6 months
- Major surgery within 4 weeks before treatment or planned during study
- Recent radiotherapy, chemotherapy, surgery, molecular targeted therapy, or unresolved toxicities from prior treatments
- Active infection, unexplained fever, or high white blood cell count before treatment
- Immunodeficiency conditions, including HIV or active hepatitis B or C infection
- Recent live or attenuated vaccination within 4 weeks before treatment or planned during study
- Any condition that could affect study results or cause early withdrawal
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
W
Wen X Liu, Doctor
CONTACT
L
Lu Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here