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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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.
17 sites in 1 country
China17 sites, 17 recruiting
- Not yet 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
- 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
- Not yet 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
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Li Wang, 86 13613718339, zlyychm@126.com
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
- Conditions
- Advanced Endometrial Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients 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 group | Active comparator | Patients 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.
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
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)
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
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
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
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
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
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
Blood concentration of fruquintinib
Steady-state blood concentration of fruquintinib
Measured: At the end of cycle 4 day 14 (each cycle is 21 days)
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
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.
- First posted4 Sep 2024
- Study start12 Dec 2024
- Primary completion8 Jan 2029 (estimated)
- Study completion9 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaohua Wu, Principal investigator, Fudan University
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