Actively Recruiting
A Phase II Study to Evaluate the Efficacy and Safety of QL1706 Combination Therapy in Immunotherapy-Pretreated Recurrent or Metastatic Endometrial Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-04-08
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating QL1706 combined with chemotherapy in patients with advanced recurrent or metastatic endometrial cancer who have progressed after prior anti-PD-1/L1 therapy. This Phase II prospective, single-arm, multicenter study focuses on the efficacy and safety of this combination treatment in patients refractory to previous PD-1/L1 inhibitor therapy. The trial aims to monitor response and survival outcomes in this patient population. Participants receive QL1706 infusion at 5 mg/kg every 3 weeks until progression, unacceptable toxicity, completion of one year of treatment, or meeting discontinuation criteria. They also receive physician's choice chemotherapy for 3 to 6 cycles, with the option of adding bevacizumab at 15 mg/kg every 3 weeks under the same treatment duration conditions. The study consists of screening, treatment, and post-treatment follow-up phases, with continuous safety monitoring throughout. During the trial, patients undergo assessments including tumor measurements by RECIST v1.1, safety evaluations, and survival follow-up for up to five years. Researchers track objective response rate, progression-free survival, overall survival, duration of response, and adverse events. Patients discontinuing treatment for reasons other than progression or death receive additional tumor progression follow-up. The total participation includes initial screening, treatment duration, and long-term safety and survival monitoring.
CONDITIONS
Brief Title
QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status score 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
- Prior anti-PD-1/L1 monoclonal antibody therapy with progression-free survival of 6 months or more
- Last dose of anti-PD-1/L1 therapy given at least 5 half-lives before current treatment
- Prior anti-angiogenic therapy allowed with a washout period of at least 5 half-lives
- Failed 2 or fewer lines of prior systemic therapy (excluding endocrine therapy)
- Discontinued all other anti-tumor therapies at least 4 weeks before treatment
- Adequate organ function on screening laboratory tests
- Negative pregnancy test for females of childbearing potential and use of effective contraception
- Signed informed consent and willingness 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
- Stopped anti-PD-1/PD-L1 therapy due to related toxicity
- Active or history of autoimmune disease requiring intervention (except resolved vitiligo or childhood asthma without treatment)
- Use of immunosuppressants or systemic corticosteroids over 10 mg/day prednisone equivalent within 2 weeks prior
- Active tuberculosis or syphilis infection
- History of allogeneic organ or stem cell transplantation
- Severe allergic reactions to monoclonal antibodies
- Interstitial lung disease or active non-infectious pneumonitis
- Known or suspected central nervous system metastases
- History of other malignancies within 3 years except certain skin or cervical cancers
- Uncontrolled hypertension or recent hypertensive crises
- Recent significant heart conditions or left ventricular ejection fraction below 50%
- Current thrombolytic or anticoagulant therapy (low-dose aspirin allowed)
- Recent arterial or venous thrombotic events
- Major vascular disease within 6 months
- Major surgery within 4 weeks before treatment
- Recent radiotherapy, chemotherapy, surgery, or unresolved toxicities from prior therapy
- Active infection or unexplained fever within 7 days
- Immunodeficiency or certain viral infections
- Live or attenuated vaccines within 4 weeks before or during study
- Any condition that may affect study results or lead to early termination
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive QL1706 combined with physician's choice chemotherapy, with or without bevacizumab. Treatment continues every 3 weeks until disease progression, unacceptable toxicity, completion of 1 year, or meeting protocol-defined discontinuation criteria.
Treatment visits every 3 weeks; chemotherapy given for 3 to 6 cycles
Duration - Up to 5 years
Participants undergo safety monitoring and survival follow-up after completing treatment. Additional tumor progression follow-up is conducted for those who discontinue treatment for reasons other than progression or death.
Periodic visits for monitoring during follow-up
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
W
Wen X Liu, Doctor
L
Lu Sun
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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