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Endometrial CancerPhase 1/2NCT04157491

Anti-PD-1 Antibody Combined With Anlotinib in the Treatment of Endometrial Cancer

A Phase 1/2 study testing anlotinib and anti PD-1 antibody in people with Endometrial Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to evaluate the Efficacy and safety of Anti-PD-1 antibody combined With anlotinib in the treatment of recurrent or advanced endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
anlotinib and anti PD-1 antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
18 Oct 2019to 31 Dec 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age and female;
  • Histologically confirmed diagnosis of endometrial cancer；
  • Patients must have received at least 1 cycle of platinum-based chemotherapy；
  • Patients with recurrent endometrial cancer that has failed at least one line of platinum-based system chemotherapy
  • Patients with newly diagnosed advanced endometrial cancer has persist lesion after standard treatment with surgery and chemotherapy ± radiotherapy （at least one line of platinum-based systemic chemotherapy）
  • At least one measurable lesion according to RECIST1.1 on CT;
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  • ECOG performance status 0-2;
  • Life expectancy ≥ 3 months;
  • Adequate hepatic, renal, heart, and hematologic functions. Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 70×109/L, Hemoglobin(HGB) ≥ 80 g/L, total bilirubin within 1.5×the upper limit of normal (ULN), and serum transaminase≤2.5×Upper Limit Of Normal(ULN), serum creatine ≤ 1.5 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥50ml/min, International Normalized Ratio<1.5 x Upper Limit Of Normal(ULN), Urinary protein≤（+）and Thyroid stimulating hormone≤ 1.5 x Upper Limit Of Normal(ULN).
  • Signed and dated informed consent.

Who cannot join

  • Pathology confirmed with sarcoma components (including malignant mixed mullerian tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma);
  • Exposured to any anti-tumor drugs within 4 weeks;
  • Less than 4 weeks since the patient underwent any major surgery or expect a major surgery during trial;
  • Radiation therapy within 21 days（Palliative radiotherapy for bone metastases within14 days）;
  • Exposured to any anti-PD1 antibody drugs；
  • Any unresolved toxicity CTCAE > Grade 1 from the prior chemoradiation therapy（Excluding hair loss and neurotoxicity）;
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  • Current or prior use of any immunosuppressive medication or systemic hormone therapy（which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid Prednisone>10mg/d）within 14 days before the first dose of anti-PD1 antibody and Anlotinib；
  • Any primary malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma);
  • History of psychiatric drugs abuse and not be abstinent, or dysphrenia；
  • Central nervous system diseases, including uncontrollable epilepsy and symptomatic brain metastases;
  • Digestive diseases that may affect drug absorption (such as atrophic gastritis)
  • Active ulcers, intestinal perforation, intractable intestinal obstruction, and history of digestive tract perforation within 28 days prior to enrollment；
  • Uncontrolled hypertension（blood pressure >140/90 mmHg after adequate treatment）;
  • Severe cardiovascular disease: unstable angina pectoris, myocardial infarction, grade III-IV cardiac insufficiency (NYHA standard), and peripheral vascular disease above 2 degrees within 6 months prior to enrollment;
  • Severe arrhythmia requiring drug control, QT interval >470ms；
  • Active hemorrhage or hemorrhage tendency.
  • Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack (TIA), hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.
  • Active infections such as HIV/AIDS or other serious infectious diseases
  • Any active autoimmune disease or history of autoimmune disease (including but not limit to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis, nephritis, hyperthyroidism, pituitary inflammation, vasculitis, uveitis) . Patients need receiving systemic hormonal therapy and/or immunosuppressive therapy (eg asthma requiring bronchodilators);
  • Receipt of live attenuated vaccination within 30 days prior to study entry;
  • Known to be allergic to any drug in the study;
  • For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study.
  • Other conditions regimented at investigators' discretion.

Trial locations and contacts

1 site in 1 country.

Jundong Li contact

+86-20-87343104

lijd@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Centre

    Guangzhou, Guangdong, 510060

    Jundong Li, +86-20-87343104, lijd@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-center, Single-arm, Phase II Trial to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody Combined With Anlotinib in the Treatment of Recurrent or Advanced Endometrial Cancer

The purpose of the study is to evaluate the Efficacy and safety of Anti-PD-1 antibody combined With anlotinib in the treatment of recurrent or advanced endometrial cancer.

Being tested
anlotinib and anti PD-1 antibody
Keywords
endometrial cancer, anlotinib, anti PD-1 antibody
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • anlotinib and anti PD-1 antibodyDrug

    Anti-PD-1 antibody administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus Anlotinib 12 mg administered orally (PO) once daily (QD) Day1-Day14 during each 21-day cycle.

Study groups in NCT04157491
Study groupRoleWhat they receive
anlotinib and anti PD-1 antibodyExperimentalNot described
Receives: Drug: anlotinib and anti PD-1 antibody

What is being measured

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

  1. Objective Response Rate(ORR)

    Objective tumor response was defined as the proportion of patients whose tumor volume has been reduced to a predetermined value and can be maintained for more than 4 weeks, ie ORR=CR+PR.

    Measured: Approximately 24 months.

Secondary outcomes (6)

  1. Duration of Response(DoR)

    Duration of response was defined as the time when the tumor is first evaluated as CR or PR to the first assessment for PD or for any cause of death.

    Measured: Approximately 24 months.

  2. Disease Control Rate(DCR)

    Disease control rate was defined as the proportion of subjects with complete response (CR) or partial response (PR) or disease stabilization (SD) in the analyzed population according to the RECIST 1.1 criteria.

    Measured: Approximately 24 months.

  3. Time to Objective Response(TTR)

    Time to objective response was defined as the time from the start of treatment to the first objective tumor remission (CR or PR).

    Measured: Approximately 24 months.

  4. Progression Free Survival(PFS)

    Progression-free survival was defined as the duration of time from study entry to time of progression, death, or the date of last contact, whichever occurs first.

    Measured: Approximately 24 months.

  5. Overall Survival（OS）

    Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

    Measured: Approximately 48 months.

  6. Overall Survival Rate at 12 months

    Overall survival rate at 12 months was defined as the proportion of patients who were still alive in 12 months.

    Measured: Approximately 12 months.

Timeline

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

  1. First posted8 Nov 2019
  2. Study start18 Oct 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2022 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04157491
Sponsor's protocol ID
SINAL1618
Status last verified
Nov 2019
First submitted
6 Nov 2019
Last updated
8 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wei W, Ban X, Yang F, Li J, Cheng X, Zhang R, Huang X, Huang Y, Li Q, Qiu Y, Zheng M, Zhu X, Li J. Phase II trial of efficacy, safety and biomarker analysis of sintilimab plus anlotinib for patients with recurrent or advanced endometrial cancer. J Immunother Cancer. 2022 May;10(5):e004338. doi: 10.1136/jitc-2021-004338.

    PubMed 35623659

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing anlotinib and anti PD-1 antibody in people with Endometrial Cancer, run by Sun Yat-sen University 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 10 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 8 Nov 2019. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Results are not available in the source record.

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

Contact Jundong Li (+86-20-87343104, lijd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: Approximately 24 months.). 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 NCT04157491, which also lists 1 linked publication.

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 8 Nov 2019.

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