Actively Recruiting
An Open-label, Multi-center, Multi-corhort Phase II 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating envafolimab alone or combined with lenvatinib in patients with advanced endometrial cancer who cannot undergo curative surgery or radiation. This Phase II open-label, multi-center study aims to measure the objective response rate to these treatments. The study is sponsored by 3D Medicines (Sichuan) Co., Ltd. and focuses on patients who have previously undergone or cannot tolerate first-line platinum-based chemotherapy. Participants receive either envafolimab alone or envafolimab combined with lenvatinib. Envafolimab is given as a 400mg dose on Day 1 and Day 15 of the first 28-day treatment cycle, then once on Day 1 of each following cycle. Lenvatinib is taken orally at 20mg daily during each 28-day cycle for those in the combination group. Treatment continues up to approximately 24 months as patients are monitored. During the study, patients will undergo regular assessments including imaging reviews to measure tumor response, along with evaluations of treatment duration, disease control, time to response, progression-free survival, and overall survival. Researchers will also monitor organ function and safety throughout the treatment period. The total duration of participant involvement can be up to about 24 months, allowing long-term observation of treatment effects and outcomes.
CONDITIONS
Brief 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.
- Have a confirmed diagnosis of endometrial carcinoma.
- Have advanced, recurrent, or metastatic endometrial cancer not suitable for curative surgery or radiation.
- Have experienced failure or intolerance to first-line platinum-based chemotherapy.
- Have at least one measurable target lesion per RECIST 1.1 criteria.
- Have ECOG performance status of 0 or 1.
- Have a life expectancy of at least 12 weeks.
- Have sufficient organ and bone marrow function without recent growth factor, blood transfusion, or platelet therapy.
- Provide archival tumor tissue or newly obtained biopsy before treatment for biomarker analysis.
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before treatment.
You will not qualify if you...
- Previous lab results showing dMMR or MSI-H.
- Participation in other investigational drug trials within 28 days before treatment.
- Anti-tumor treatment within 2 weeks before study drug.
- Unresolved toxicity from prior treatments above grade 1.
- Major surgery within 28 days before treatment or serious nonhealing wounds.
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or related checkpoint inhibitors.
- Uncontrolled blood pressure above 150/90 mmHg.
- Uncontrolled or major cardio-cerebral vascular disease.
- Active or recurrent autoimmune disease requiring systemic treatment.
- Use of systemic corticosteroids above 10 mg prednisone equivalent within 14 days before treatment.
- Recent live-virus vaccination within 28 days before treatment.
- Current or suspected non-infectious pneumonitis.
- Active infection requiring systemic treatment.
- Active hepatitis B or C infection.
- Positive for HIV.
- Uncontrolled pericardial, pleural effusion, or ascites.
- Symptomatic or active brain metastases or meningeal carcinomatosis.
- Other malignant tumors within 5 years except certain skin cancers.
- Hypersensitivity to study drugs or components.
- Pregnant or breastfeeding females not using 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 disorder within 6 months before treatment.
- Any other investigator-judged factors preventing enrollment.
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 24 months
Participants receive envafolimab alone or combined with lenvatinib in repeated 28-day cycles. Envafolimab is administered once on Day 1 and Day 15 of the first cycle and once on Day 1 of each subsequent cycle. Lenvatinib is taken orally daily during each 28-day cycle for participants assigned to combination treatment.
Visits on Day 1 and Day 15 of the first cycle, then Day 1 of each 28-day cycle
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
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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