Trial Title:
Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
NCT ID:
NCT06584032
Condition:
Advanced Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Paclitaxel
Doxorubicin
Conditions: Keywords:
fruquintinib
sintilimab
endometrial cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
fruquintinib
Description:
Fruquintinib will be orally administrated once daily for 2 consecutive weeks followed by
a 1-week break.
Arm group label:
Experimental group
Other name:
HMPL-013
Intervention type:
Biological
Intervention name:
sintilimab
Description:
Sintilimab will be intravenously administrated on Day 1 every three weeks.
Arm group label:
Experimental group
Other name:
IBI308
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
175 mg/m^2 via IV infusion, once a week for 3 weeks followed by a 1-week break.
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
doxorubicin
Description:
60mg/m^2 via IV infusion, on Day 1 every three weeks.
Arm group label:
Control group
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).
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Have fully understood and voluntarily signed the informed consent form
2. Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg/m^2;
3. Histologically or cytologically confirmed advanced or recurrent endometrial cancer
with measurable lesions
4. Patients who previously failed first-line systemic platinum-based therapy
5. ECOG PS (Eastern Cooperative Oncology Group performance status score) 0 or 1;
6. Need to provide tumor samples for central lab testing of biomarkers such as
MSI(microsatellite instability) status;
7. Non-MSI-H(non-microsatellite instability-high) by central lab or previous test
result indicating pMMR(proficient mismatch repair);
8. Adequate function of the major organs;
9. Expected survival ≥ 12 weeks;
10. Female patients of childbearing potential must have a negative serum pregnancy test
within 7 days before randomization.
Exclusion Criteria:
1. Endometrial carcinosarcoma or sarcoma;
2. Known MMR(mismatch repair)/MSI status with dMMR(deficient mismatch repair) or
MSI-H(microsatellite instability-high);
3. Toxicities related to prior anticancer therapy did not recover to ≤CTCAE Grade 1,
except alopecia and oxaliplatin-induced peripheral neurotoxicity ≤CTCAE Grade 2;
4. Received systemic anti-tumor therapy approved within 4 weeks before randomization;
5. Other malignancies within the past 5 years;
6. Previous or screening central nervous system (CNS) metastases;
7. Radical radiotherapy within 4 weeks before randomization
8. 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;
9. Symptomatic or treatment-requiring thyroid dysfunction at screening;
10. Use of immunosuppressive agents within 4 weeks before randomization
11. Presence of any active autoimmune disease requiring systemic treatment or history of
autoimmune disease within the past 2 years;
12. Systemic immunostimulants within 4 weeks before randomization;
13. Administration of any live or live-attenuated vaccine within 4 weeks before
randomization or planned during the study;
14. Major surgical procedures within 4 weeks before randomization;
15. Uncontrolled malignant pleural effusion, ascites or pericardial effusion;
16. Patients with current hypertension uncontrolled by medication;
17. Patients with any current disease or condition affecting drug absorption, or
patients unable to take oral medications;
18. Receiving strong inducers of cytochrome P450 3A4 enzyme;
19. 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;
20. Active bleeding within 3 weeks before randomization, or melena, or bleeding from a
tumor within 2 weeks before the first dose ;
21. Tumor invading major vascular structures and is judged by the investigator to be at
greater risk of massive haemorrhage;
22. 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;
23. Clinically significant cardiovascular disease;
24. Clinically significant electrolyte abnormalities as judged by the investigator;
25. Active infection or fever of unknown origin before randomization;
26. Patients with active pulmonary tuberculosis (TB) receiving anti-tuberculosis
treatment or anti-tuberculosis treatment within 1 year before randomization;
27. 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;
28. Positive human immunodeficiency virus (HIV) antibody screening;
29. Known history of clinically significant liver disease
30. Known hypersensitivity to any of the study drugs or any of their excipients, or
previous history of serious hypersensitivity to any other monoclonal antibody;
31. Patients who have received other clinical drugs that have not been approved or
marketed within 4 weeks before randomization;
32. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
33. Patients who have received tissue/organ transplantation;
34. Patients with known psychiatric disorders or substance abuse disorders that could
affect study compliance;
35. Patients who, in the opinion of the investigator, have other reasons that would make
them inappropriate for this clinical study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Obstetrics and Gynecology Hospital
Address:
City:
Beijing
Zip:
100026
Country:
China
Contact:
Last name:
Yumei Wu
Phone:
86 13701016571
Email:
wym597118@163.com
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Contact:
Last name:
Dong Wang
Phone:
86 13708301293
Email:
cqwindow120@163.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Contact:
Last name:
Yang Sun
Phone:
86 15959028989
Email:
doctorsunyang@sina.com
Facility:
Name:
SUN Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510050
Country:
China
Contact:
Last name:
Jihong Liu
Phone:
86 13826299236
Email:
liujh@sysucc.org.cn
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530012
Country:
China
Contact:
Last name:
Zhijun Yang
Phone:
86 15278015900
Email:
1583825050@qq.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Contact:
Last name:
Xiuwei Chen
Phone:
86 13945187909
Email:
chenxiuwei1023@163.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Contact:
Last name:
Li Wang
Phone:
86 13613718339
Email:
zlyychm@126.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Contact:
Last name:
Jing Wang
Phone:
86 13875902083
Email:
wangjing189@163.com
Facility:
Name:
Xijing Hospital of Air Force Military Medical University
Address:
City:
Xian
Zip:
710032
Country:
China
Contact:
Last name:
Hong Yang
Phone:
86 13909288687
Email:
yanghong@fmmu.edu.cn
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Contact:
Last name:
Hao Yu
Phone:
86 15953105039
Email:
fishdoctor@yeah.net
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Xiaohua Wu
Phone:
86 13601772486
Email:
docwuxh@hotmail.com
Facility:
Name:
Sencond Hospital of Shanxi Medical University
Address:
City:
Taiyuan
Zip:
030001
Country:
China
Contact:
Last name:
Wei Wag
Phone:
86 13834140764
Email:
eryuanwangwei@163.com
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Contact:
Last name:
Ke Wang
Phone:
86 18622221098
Email:
18622080116@163.com
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Contact:
Last name:
Hongying Yang
Phone:
86 13888087358
Email:
hxf960726451@163.com
Facility:
Name:
Women's Hospital school of Medical Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Contact:
Last name:
Weiguo Lv
Phone:
86 057187061501
Email:
lbwg@zju.edu.cn
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Contact:
Last name:
Hanmei Lou
Phone:
86 13355783145
Email:
louhm@zjcc.org.cn
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325015
Country:
China
Contact:
Last name:
Xiaojian Yan
Phone:
86 13968891620
Email:
yxjbetter@126.com
Start date:
November 6, 2024
Completion date:
June 9, 2029
Lead sponsor:
Agency:
Hutchmed
Agency class:
Industry
Source:
Hutchmed
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06584032
