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Endometrial AdenocarcinomaPhase 2QLPPEC/GOG-003NCT06917092

QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer

A Phase 2 study testing QL1706 combined with chemotherapy ± Bevacizumab in people with Endometrial Adenocarcinoma and Endometrial Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
QL1706 combined with chemotherapy ± Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
16 Jun 2025to 30 Apr 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 half-lives before the initiation of the current treatment.
  • 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.
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  • 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 subjects 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 male partner, the subject must use an acceptable and highly effective contraceptive method since screening and must agree to continue such precautions until 6 months after the last dose of the study drug; periodic abstinence and the rhythm method are not acceptable forms of contraception.
  • Voluntarily sign the informed consent form, understand the nature, purpose, and procedures of the trial, and willingly comply with the trial requirements.

Who cannot join

  • 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, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; asthma requiring bronchodilator treatment is excluded).
  • 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.
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  • 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 CNS metastases must be excluded via CT/MRI.
  • 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 <50% within 6 months before the first dose.
  • 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 <4 weeks before study treatment; molecular targeted therapy (including other investigational oral targeted agents) <5 half-lives before study treatment; or unresolved toxicities (>CTCAE grade 1, except alopecia) from prior therapy.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wen X Liu, Doctor contact

+86 13702169191

wenxin1973@163.com

Lu Sun contact

+86 18722068811

sun_sl2006@126.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study to Evaluate the Efficacy and Safety of QL1706 Combination Therapy in Immunotherapy-Pretreated Recurrent or Metastatic Endometrial Cancer

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.

Read the detailed description

This prospective, single-arm, multicenter Phase II study evaluates the efficacy and safety of QL1706 plus physician's choice chemotherapy (with or without bevacizumab) in patients with advanced recurrent or metastatic endometrial cancer refractory to prior PD-1/L1 inhibitor therapy. The study consists of three phases: screening, treatment, and post-treatment follow-up, with continuous safety monitoring throughout. Eligible patients had confirmed disease progression following previous PD-1/L1 inhibitor treatment. Participants received QL1706 combined with physician's choice chemotherapy, with or without bevacizumab. All participants will undergo post-treatment safety monitoring and survival follow-up after treatment completion. For patients who discontinue treatment for reasons other than disease progression or death, additional tumor progression follow-up will be conducted post-treatment.

Being tested
QL1706 combined with chemotherapy ± Bevacizumab
Keywords
Immunotherapy-Pretreated, Recurrent or Metastatic Endometrial Carcinoma, Immune Checkpoint Inhibitors, QL1706
Medical subject headings
Endometrial Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1706 combined with chemotherapy ± BevacizumabDrug

    • Drug: QL1706: 5 mg/kg IV every 3 weeks until progression, unacceptable toxicity, completion of 1 year of treatment, or meeting protocol-defined discontinuation criteria, whichever occurred first.
    • Drug: Chemotherapy: physician's choice chemotherapy for 3-6 cycles.
    • Drug: Bevacizumab (optional): 15 mg/kg IV every 3 weeks until progression, unacceptable toxicity, completion of 1 year of treatment, or meeting protocol-defined discontinuation criteria, whichever occurred first.
Study groups in NCT06917092
Study groupRoleWhat they receive
QL1706 Combination TherapyExperimentalQL1706 Combination Therapy in Immunotherapy-Pretreated Recurrent or Metastatic Endometrial Carcinoma
Receives: Drug: QL1706 combined with chemotherapy ± Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) - Investigator assessment

    the objective response rate (ORR) of treatment with QL1706 combined with chemotherapy ± Bevacizumab, as assessed by the Investigator per RECIST v.1.1.

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Progression-Free Survival (PFS) - investigator assessment

    the Progression-Free Survival (PFS) of treatment with QL1706 combined with chemotherapy ± Bevacizumab, as assessed by the Investigator per RECIST v.1.1.

    Measured: Up to 5 years

  2. Overall survival (OS)

    the overall survival (OS) of treatment with QL1706 combined with chemotherapy ± Bevacizumab, as assessed by the Investigator per RECIST v.1.1.

    Measured: Up to 5 years

  3. Duration of response (DOR) - Investigator assessment

    the duration of response (DOR) of treatment with QL1706 combined with chemotherapy ± Bevacizumab, as assessed by the Investigator per RECIST v.1.1.

    Measured: Up to 5 years

  4. Number of participants with adverse events (AEs), Serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2025
  2. Study start16 Jun 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06917092
Sponsor's protocol ID
E20250167
Acronym
QLPPEC/GOG-003
Status last verified
Oct 2026
First submitted
1 Apr 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706 combined with chemotherapy ± Bevacizumab in people with Endometrial Adenocarcinoma and Endometrial Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wen X Liu, Doctor (+86 13702169191, wenxin1973@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) - Investigator assessment (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06917092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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