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New treatment option for Endometrial Adenocarcinoma
Official title QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer
ClinicalTrials.gov ID: NCT06917092
What this study is testing
What is QL1706 combined with chemotherapy ± Bevacizumab?
QL1706 combined with chemotherapy ± Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Age ≥18 years and ≤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 criteria.
- Patients must have received prior anti-PD-1/L1 monoclonal antibody (mAb) therapy with a progression-free survival (PFS) of ≥6 months; however, the...
You likely can't join if
- 1\. Previous treatment with PD-1/CTLA-4 dual-target immunotherapy, immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.)...
- 2\. Discontinuation of anti-PD-1/PD-L1 antibody therapy due to related toxicity. 3. Presence of any active autoimmune disease or history of...
- 4\. Current use of immunosuppressants or systemic corticosteroids for immunosuppression (dose \>10 mg/day prednisone or equivalent) within 2 weeks...
- 5\. Known active tuberculosis (TB) or suspected active TB requiring clinical evaluation for exclusion; known active syphilis infection.
- 6\. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 7\. History of severe allergic reactions to monoclonal antibodies. 8. Known history or evidence of interstitial lung disease or active non-infectious...
See the full eligibility criteria
Who can join
- Age ≥18 years and ≤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 criteria.
- Patients must have received prior anti-PD-1/L1 monoclonal antibody (mAb) therapy with a progression-free survival (PFS) of ≥6 months; however, the last dose of anti-PD-1/L1 mAb must have been administered at least 5...
- Patients who have received prior anti-angiogenic therapy are eligible, provided there is a washout period of at least 5 half-lives before re-administration.
- Patients who have failed ≤2 lines of prior systemic therapy are eligible (endocrine therapy is not counted as a line of treatment).
- All other anti-tumor therapies must be discontinued at least 4 weeks before treatment initiation. Patients taking hormonal medications require a 30-day washout period.
- Laboratory tests during the screening period must demonstrate adequate organ function.
- Female people of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. If a female subject of childbearing potential engages in sexual activity with a non-sterilized...
- Voluntarily sign the informed consent form, understand the nature, purpose, and procedures of the trial, and willingly comply with the trial requirements.
What rules you out
- 1\. Previous treatment with PD-1/CTLA-4 dual-target immunotherapy, immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), or immune cell therapy.
- 2\. Discontinuation of anti-PD-1/PD-L1 antibody therapy due to related toxicity. 3. Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis...
- 4\. Current use of immunosuppressants or systemic corticosteroids for immunosuppression (dose \>10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment.
- 5\. Known active tuberculosis (TB) or suspected active TB requiring clinical evaluation for exclusion; known active syphilis infection.
- 6\. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 7\. History of severe allergic reactions to monoclonal antibodies. 8. Known history or evidence of interstitial lung disease or active non-infectious pneumonitis.
- 9\. History or current presence of central nervous system (CNS) metastases. Baseline imaging to confirm the absence of brain metastases is not mandatory. Patients with unknown CNS status but clinical signs suggestive of...
- 10\. History of other malignancies (except non-melanoma skin cancer or cervical carcinoma in situ; patients with other prior malignancies must have been disease-free for at least 3 years).
- 11\. Uncontrolled hypertension despite antihypertensive therapy (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg); hypertensive crisis or hypertensive encephalopathy in the past.
- 12\. History of unstable angina, myocardial infarction (MI), chronic heart failure (CHF), clinically significant arrhythmias requiring treatment (except stable atrial fibrillation), or left ventricular ejection fraction...
- 13\. Current thrombolytic or anticoagulant therapy (prophylactic low-dose aspirin or low molecular weight heparin is permitted).
- 14\. Arterial/venous thrombotic events within 6 months before enrollment (e.g., cerebrovascular accident, transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism).
- 15\. Major vascular disease within 6 months before study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis).
- 16\. Major surgery within 4 weeks before study treatment (excluding diagnostic procedures) or anticipated major surgery during the study.
- 17\. Prior radiotherapy (except palliative bone radiotherapy), chemotherapy, or surgery (excluding biopsy) within 4 weeks before the first study dose; last antibody dose \ CTCAE grade 1, except alopecia) from prior...
- 18\. Active infection, unexplained fever ≥38.5°C within 7 days before treatment, or baseline white blood cell count \>15×10⁹/L.
- 19\. Congenital or acquired immunodeficiency (e.g., HIV infection); HBsAg-positive with HBV DNA ≥2000 IU/mL, or HCV antibody-positive.
- 20\. Live/attenuated vaccination within 4 weeks before study treatment or anticipated during the study.
- 21\. Any other condition deemed by the investigator to potentially affect study results or lead to premature termination.
- 22\. Pregnant or breastfeeding women.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.