Actively Recruiting
A Randomized, Open-label, Multicenter Phase III Study to Evaluate Fruquintinib Plus Sintilimab Versus Physician's Choice Chemotherapy as Second-line Treatment for Advanced Endometrial Cancer
Led by Hutchmed · Updated on 2025-01-07
412
Participants Needed
17
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of fruquintinib (HMPL-013) combined with sintilimab (IBI308) compared to chemotherapy in treating advanced endometrial cancer. This Phase III randomized, open-label, multicenter study focuses on patients whose cancer has progressed after first-line platinum-based chemotherapy. The purpose is to determine if this combination therapy offers benefits over physician-chosen chemotherapy options such as paclitaxel or doxorubicin. Participants will be randomly assigned to one of two groups. One group will receive fruquintinib orally once daily for two weeks followed by a one-week break, plus sintilimab intravenously every three weeks. The other group will receive chemotherapy with either paclitaxel weekly for three weeks followed by a one-week break or doxorubicin every three weeks. Treatment continues until disease progression confirmed by an independent review committee or other discontinuation criteria are met. Throughout the study, participants will undergo regular assessments including scans and tests to monitor disease progression and response. Researchers will track progression-free survival and overall survival for up to approximately four years. Additional evaluations include tumor response rates, duration of response, disease control, quality of life questionnaires, and safety monitoring. Blood samples will be collected to measure drug levels. The total study duration for each participant may last up to several years with ongoing follow-up.
CONDITIONS
Brief Title
Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have fully understood and voluntarily signed the informed consent form
- Age 18 to 75 years (inclusive); Body mass index (BMI) 218.5 kg/m^2
- 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 score of 0 or 1
- Provide tumor samples for central lab biomarker testing including MSI status
- Non-microsatellite instability-high (non-MSI-H) or proficient mismatch repair (pMMR)
- Adequate function of major organs
- 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...
- Diagnosed with endometrial carcinosarcoma or sarcoma
- Known mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
- Toxicities from prior anticancer therapy not recovered to CTCAE Grade 1, except alopecia and certain neuropathies
- Received systemic anti-tumor therapy 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 use of PD-1, PD-L1, PD-L2, CTLA-4 antibodies or VEGFR tyrosine kinase inhibitors
- Symptomatic or treatment-requiring thyroid dysfunction at screening
- Use of immunosuppressive agents or systemic immunostimulants within 4 weeks before randomization
- Live or live-attenuated vaccine administration 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
- Conditions affecting drug absorption or inability to take oral medications
- Use of strong cytochrome P450 3A4 inducers
- Gastrointestinal diseases causing bleeding or perforation risks
- Active bleeding or bleeding from tumor within specified timeframes
- Tumor invading major vascular structures with high hemorrhage risk
- Recent arterial or venous thrombosis or stroke
- Significant cardiovascular disease or electrolyte abnormalities
- Active infection or fever of unknown origin
- Active pulmonary tuberculosis or history of pulmonary diseases affecting lung function
- Positive HIV antibody screening
- Clinically significant liver disease
- Known hypersensitivity to study drugs or monoclonal antibodies
- Receipt of unapproved clinical drugs within 4 weeks before randomization
- Pregnant or breastfeeding women
- History of 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 years
Participants receive treatment with either fruquintinib plus sintilimab or chemotherapy of physician's choice until disease progression or meeting other discontinuation criteria.
Treatment visits every 3 weeks; fruquintinib taken orally daily for 2 weeks followed by 1 week break; sintilimab given intravenously on Day 1 every 3 weeks; chemotherapy given every 3 or 4 weeks depending on regimen
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
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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