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Advanced Endometrial CancerPhase 3NCT06584032

Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer

A Phase 3 study testing fruquintinib, sintilimab and paclitaxel in people with Advanced Endometrial Cancer, run by Hutchmed at 17 sites 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

The goal of this study is to evaluate whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC). Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Advanced Endometrial Cancer
What is being tested?
fruquintinib, sintilimab and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
17 sitesChina
Study dates
12 Dec 2024to 9 Jun 2029
Phase
Phase 3
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have fully understood and voluntarily signed the informed consent form
  • Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg/m^2;
  • Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions
  • Patients who previously failed first-line systemic platinum-based therapy
  • ECOG PS (Eastern Cooperative Oncology Group performance status score) 0 or 1;
  • Need to provide tumor samples for central lab testing of biomarkers such as MSI(microsatellite instability) status;
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  • Non-MSI-H(non-microsatellite instability-high) by central lab or previous test result indicating pMMR(proficient mismatch repair);
  • Adequate function of the major organs;
  • Expected survival ≥ 12 weeks;
  • Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization.

Who cannot join

  • Endometrial carcinosarcoma or sarcoma;
  • Known MMR(mismatch repair)/MSI status with dMMR(deficient mismatch repair) or MSI-H(microsatellite instability-high);
  • Toxicities related to prior anticancer therapy did not recover to ≤CTCAE Grade 1, except alopecia and oxaliplatin-induced peripheral neurotoxicity ≤CTCAE Grade 2;
  • Received systemic anti-tumor therapy approved within 4 weeks before randomization;
  • Other malignancies within the past 5 years;
  • Previous or screening central nervous system (CNS) metastases;
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  • Radical radiotherapy within 4 weeks before randomization
  • Previously received any anti-programmed cell death receptor-1 (PD-1) antibody, anti-PD-L1(programmed death ligand-1) antibody, anti-PD-L2(programmed death ligand-2) antibody, or anti cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody acting on T cell costimulation or checkpoint pathways (eg, OX40, CD137, etc) or small molecule vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors;
  • Symptomatic or treatment-requiring thyroid dysfunction at screening;
  • Use of immunosuppressive agents within 4 weeks before randomization
  • Presence of any active autoimmune disease requiring systemic treatment or history of autoimmune disease within the past 2 years;
  • Systemic immunostimulants within 4 weeks before randomization;
  • Administration of any live or live-attenuated vaccine within 4 weeks before randomization or planned during the study;
  • Major surgical procedures within 4 weeks before randomization;
  • Uncontrolled malignant pleural effusion, ascites or pericardial effusion;
  • Patients with current hypertension uncontrolled by medication;
  • Patients with any current disease or condition affecting drug absorption, or patients unable to take oral medications;
  • Receiving strong inducers of cytochrome P450 3A4 enzyme;
  • Patients with gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; or with gastrointestinal perforation or gastrointestinal fistula, which is not recovered after surgical treatment;
  • Active bleeding within 3 weeks before randomization, or melena, or bleeding from a tumor within 2 weeks before the first dose ;
  • Tumor invading major vascular structures and is judged by the investigator to be at greater risk of massive haemorrhage;
  • Patients who had arterial thrombosis or deep venous thrombosis within 6 months before randomization; or patients who had stroke events and/or transient ischemic attack within 12 months; patients who had thrombosis caused by implantable intravenous infusion pump or catheter, except patients who had stable thrombosis after conventional anticoagulant therapy;
  • Clinically significant cardiovascular disease;
  • Clinically significant electrolyte abnormalities as judged by the investigator;
  • Active infection or fever of unknown origin before randomization;
  • Patients with active pulmonary tuberculosis (TB) receiving anti-tuberculosis treatment or anti-tuberculosis treatment within 1 year before randomization;
  • Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, which may interfere with the detection and management of suspected drug-related pulmonary toxicity; previous or current (non-infectious) pulmonary inflammation requiring steroid hormone therapy;
  • Positive human immunodeficiency virus (HIV) antibody screening;
  • Known history of clinically significant liver disease
  • Known hypersensitivity to any of the study drugs or any of their excipients, or previous history of serious hypersensitivity to any other monoclonal antibody;
  • Patients who have received other clinical drugs that have not been approved or marketed within 4 weeks before randomization;
  • Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
  • Patients who have received tissue/organ transplantation;
  • Patients with known psychiatric disorders or substance abuse disorders that could affect study compliance;
  • Patients who, in the opinion of the investigator, have other reasons that would make them inappropriate for this clinical study.

Trial locations and contacts

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

Panfeng Tan contact

86-21-20671828

panfengt@hutch-med.com

17 sites in 1 country

China17 sites, 17 recruiting

  • Beijing Obstetrics and Gynecology Hospital

    Beijing, Beijing Municipality, 100026

    Yumei Wu, 86 13701016571, wym597118@163.com

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Jing Wang, 86 13875902083, wangjing189@163.com

    Not yet recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Dong Wang, 86 13708301293, cqwindow120@163.com

    Not yet recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Yang Sun, 86 15959028989, doctorsunyang@sina.com

    Not yet recruiting

  • SUN Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510050

    Jihong Liu, 86 13826299236, liujh@sysucc.org.cn

    Not yet recruiting

  • Women's Hospital school of Medical Zhejiang University

    Hangzhou, Zhejiang, 310003

    Weiguo Lv, 86 057187061501, lbwg@zju.edu.cn

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310005

    Hanmei Lou, 86 13355783145, louhm@zjcc.org.cn

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Xiuwei Chen, 86 13945187909, chenxiuwei1023@163.com

    Not yet recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Hao Yu, 86 15953105039, fishdoctor@yeah.net

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

    Hongying Yang, 86 13888087358, hxf960726451@163.com

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530012

    Zhijun Yang, 86 15278015900, 1583825050@qq.com

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Xiaohua Wu, 86 13601772486, docwuxh@hotmail.com

    Recruiting

  • Sencond Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Wei Wag, 86 13834140764, eryuanwangwei@163.com

    Not yet recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

    Ke Wang, 86 18622221098, 18622080116@163.com

    Not yet recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325015

    Xiaojian Yan, 86 13968891620, yxjbetter@126.com

    Not yet recruiting

  • Xijing Hospital of Air Force Military Medical University

    Xi'an, Shaanxi, 710032

    Hong Yang, 86 13909288687, yanghong@fmmu.edu.cn

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450003

    Li Wang, 86 13613718339, zlyychm@126.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized,Open-label,Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab Versus Chemotherapy of the Treating Physician's Choice as Second-line Treatment for Advanced Endometrial Cancer

The goal of this study is to evaluate whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).

Read the detailed description

A randomized, open, positive-controlled, multicenter Phase III clinical study to compare the efficacy and safety of fruquintinib(HMPL-013) plus sintilimab(IBI308) versus chemotherapy in patients with advanced endometrial cancer who have progressed after first-line standard chemotherapy

Being tested
fruquintinib, sintilimab, paclitaxel, doxorubicin
Keywords
fruquintinib, sintilimab, endometrial cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • fruquintinibDrug

    Also called HMPL-013

    Fruquintinib will be orally administrated once daily for 2 consecutive weeks followed by a 1-week break.

  • sintilimabBiological

    Also called IBI308

    Sintilimab will be intravenously administrated on Day 1 every three weeks.

  • paclitaxelDrug

    175 mg/m^2 via IV infusion, once a week for 3 weeks followed by a 1-week break.

  • doxorubicinDrug

    60mg/m^2 via IV infusion, on Day 1 every three weeks.

Study groups in NCT06584032
Study groupRoleWhat they receive
Experimental groupExperimentalPatients will be treated with a planned dose of fruquintinib and sintilimab every three weeks until an IRC (independent review committee)-confirmed PD(disease progression) or meeting other discontinuation criteria.
Receives: Drug: fruquintinib; Biological: sintilimab
Control groupActive comparatorPatients will be treated with TPC (chemotherapy of treating physician's choice, paclitaxel or doxorubicin) every three or four weeks until IRC-confirmed PD or meeting other discontinuation criteria.
Receives: Drug: paclitaxel; Drug: doxorubicin

What is being measured

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

  1. Progression-Free Survival (PFS) as assessed by IRC

    Progression-free survival (PFS) is defined as the time from randomization to disease progression assessed by IRC or death due to any cause, whichever occurs first.

    Measured: Up to approximately 4 years

  2. Overall Survival (OS)

    Overall Survival (OS) is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 4 years

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR) , as assessed by IRC and investigator.

    Measured: Up to approximately 4 years

  2. Duration of Response (DoR)

    For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first ,as assessed by IRC and investigator.

    Measured: Up to approximately 4 years

  3. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR) or maintained a stable disease, as assessed by IRC and investigator.

    Measured: Up to approximately 4 years

  4. Time To Response (TTR)

    Time To Response (TTR) is defined as the time from the start of treatment to the first objective response rate (ORR) ,as assessed by IRC and investigator.

    Measured: Up to approximately 4 years

  5. Progression-Free Survival (PFS) as assessed by investigator

    Progression-Free Survival is defined as the time from randomization to disease progression assessed by investigator or death due to any cause, whichever occurs first.

    Measured: Up to approximately 4 years

  6. Incidence and severity of Treatment-emergent Adverse Events (TEAE)

    Adverse events classified according to NCI CTCAE version 5.0

    Measured: Up to approximately 4 years

  7. Blood concentration of fruquintinib

    Steady-state blood concentration of fruquintinib

    Measured: At the end of cycle 4 day 14 (each cycle is 21 days)

  8. Health-related quality of life (using EORTC QLQ-C30)

    Changes in EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) scores from baseline

    Measured: Up to approximately 4 years

  9. Health-related quality of life (using EORTC QLQ-EN24)

    Changes in EORTC QLQ-EN24 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module) scores from baseline

    Measured: Up to approximately 4 years

Timeline

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

  1. First posted4 Sep 2024
  2. Study start12 Dec 2024
  3. Primary completion8 Jan 2029 (estimated)
  4. Study completion9 Jun 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
412 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06584032
Sponsor's protocol ID
2024-013-00CH1
Status last verified
Jan 2025
First submitted
21 Aug 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fruquintinib, sintilimab and paclitaxel in people with Advanced Endometrial Cancer, run by Hutchmed at 17 sites 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 35 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 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Panfeng Tan (86-21-20671828, panfengt@hutch-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) as assessed by IRC (time frame: Up to approximately 4 years). The study lists 2 primary outcomes in all. 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 NCT06584032.

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 7 Jan 2025.

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