Actively Recruiting
Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
Led by Hutchmed · Updated on 2025-01-07
412
Participants Needed
17
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand and voluntarily sign the informed consent form
- Age between 18 and 75 years inclusive; Body mass index (BMI) of at least 18.5 kg/m²
- Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions
- Previously failed first-line systemic platinum-based therapy
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Able to provide tumor samples for central lab biomarker testing including microsatellite instability (MSI) status
- Non-MSI-High (non-MSI-H) status by central lab or previous test indicating proficient mismatch repair (pMMR)
- Adequate major organ function
- Expected survival of at least 12 weeks
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization
You will not qualify if you...
- Diagnosis of endometrial carcinosarcoma or sarcoma
- Known deficient mismatch repair (dMMR) or MSI-High (MSI-H) status
- Toxicities from prior anticancer therapy not recovered to CTCAE Grade 1 except alopecia and oxaliplatin-induced peripheral neurotoxicity up to Grade 2
- Systemic anti-tumor therapy approved within 4 weeks before randomization
- Other malignancies within the past 5 years
- Previous or current central nervous system metastases
- Radical radiotherapy within 4 weeks before randomization
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or similar immune checkpoint inhibitors or VEGFR tyrosine kinase inhibitors
- Symptomatic or treatment-requiring thyroid dysfunction at screening
- Use of immunosuppressive agents within 4 weeks before randomization
- Active autoimmune disease requiring systemic treatment or history within past 2 years
- Systemic immunostimulants within 4 weeks before randomization
- Live or live-attenuated vaccine use within 4 weeks before randomization or planned during study
- Major surgery within 4 weeks before randomization
- Uncontrolled malignant pleural effusion, ascites, or pericardial effusion
- Uncontrolled hypertension
- Diseases affecting drug absorption or inability to take oral medication
- Use of strong cytochrome P450 3A4 inducers
- Gastrointestinal diseases with active bleeding or risk of bleeding/perforation
- Active bleeding within 3 weeks before randomization or tumor bleeding within 2 weeks before first dose
- Tumor invading major blood vessels with high hemorrhage risk
- Recent arterial or venous thrombosis or stroke events within specified time frames
- Significant cardiovascular disease
- Significant electrolyte abnormalities
- Active infection or fever of unknown origin before randomization
- Active pulmonary tuberculosis under treatment or within 1 year prior
- History or current pulmonary diseases affecting lung function or steroid-requiring inflammation
- Positive HIV antibody screening
- Clinically significant liver disease
- Hypersensitivity to study drugs or related monoclonal antibodies
- Recent use of unapproved clinical drugs within 4 weeks before randomization
- Pregnancy or breastfeeding
- Previous tissue or organ transplantation
- Psychiatric or substance abuse disorders affecting compliance
- Other investigator-determined reasons making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Beijing Obstetrics and Gynecology Hospital
Beijing, Beijing Municipality, China, 100026
Not Yet Recruiting
2
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Not Yet Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
4
SUN Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510050
Not Yet Recruiting
5
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530012
Actively Recruiting
6
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
8
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
9
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China, 710032
Not Yet Recruiting
10
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
11
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
12
Sencond Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
13
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
14
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
15
Women's Hospital school of Medical Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
16
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Not Yet Recruiting
17
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325015
Not Yet Recruiting
Research Team
P
Panfeng Tan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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