Actively Recruiting
Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer
Led by 3D Medicines (Sichuan) Co., Ltd. · Updated on 2026-03-25
108
Participants Needed
19
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multi-center, multi-corhort Phase II study of Envafolimab alone or with Lenvatinib in patients with advanced endometrial cancer.The primary objective is to evaluate objective response rate of envafolimab alone or with lenvatinib.
CONDITIONS
Official Title
Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and sign the informed consent form.
- Histologically confirmed diagnosis of endometrial carcinoma.
- Advanced, recurrent, or metastatic endometrial cancer not suitable for curative surgery or radiation.
- Failure or intolerance of first-line platinum-based chemotherapy.
- At least one measurable target lesion per RECIST 1.1 confirmed by independent review.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate organ and bone marrow function without recent growth factor or transfusion support.
- Archival or new tumor tissue sample available for biomarker analysis from untreated lesions.
- Negative pregnancy test within 7 days before first study drug dose for females of childbearing potential.
You will not qualify if you...
- Known dMMR or MSI-H status.
- Participation in other investigational drug trials within 28 days before first treatment.
- Anti-tumor treatments within 2 weeks prior to study drug.
- Unresolved toxicities from previous treatments greater than grade 1.
- Major surgery within 28 days before first treatment or serious wounds/fractures.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar immune checkpoint therapies.
- Uncontrolled blood pressure (>150/90 mmHg).
- Uncontrolled or major cardiovascular or cerebrovascular disease.
- Active or recurrent autoimmune diseases requiring systemic treatment.
- Use of systemic corticosteroids (>10 mg prednisone equivalent) within 14 days before treatment.
- Live-virus vaccination within 28 days before or planned during study.
- Current or suspected pneumonitis.
- Active infection requiring systemic treatment.
- Active Hepatitis B or C infection.
- HIV positive.
- Uncontrolled pericardial, pleural effusion, or ascites.
- Symptomatic or active brain metastasis or meningeal carcinomatosis unless clinically stable.
- Other malignancies within 5 years except certain treated skin cancers.
- Hypersensitivity to study drugs or components.
- Pregnant or breastfeeding females who do not agree to effective contraception.
- Prior treatment targeting VEGF angiogenesis.
- Radiographic evidence of major blood vessel invasion.
- History of hypertensive crisis or encephalopathy.
- Gastrointestinal conditions affecting lenvatinib absorption.
- Serious bleeding disease within 6 months before treatment.
- Any other investigator-determined factors making participation unsafe or unsuitable.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China, 40030
Actively Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
4
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China, 510120
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
6
Wuhan Union Hospital of China
Wuhan, Hubei, China, 430022
Actively Recruiting
7
:Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Actively Recruiting
8
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 200001
Actively Recruiting
9
Yueyang Center Hospital
Yueyang, Hunan, China, 414604
Actively Recruiting
10
:Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Actively Recruiting
11
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, China, 341005
Actively Recruiting
12
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110801
Actively Recruiting
13
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250063
Actively Recruiting
14
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
15
:Linyi Cancer Hospital
Linyi, Shandong, China, 276002
Actively Recruiting
16
Tai'an Center Hospital
Tai’an, Shandong, China, 271099
Actively Recruiting
17
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
18
Tianjin Medical University Cancer Institute&Hospital
Tianjing, Tianjing, China, 300181
Actively Recruiting
19
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
Research Team
B
bin She
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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