Advanced or recurrent endometrial cancer
Conditions
Interventions
experimental group:Fruquintinib
Sponsors
Shanghai tenth People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years; 2. Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable or evaluable lesions as assessed by the investigator according to RECIST 1.1; 3. Endometrial cancer patients who have failed prior systemic antitumor therapy and are not suitable for radical surgical or radical radiotherapy; 4. ECOG performance status score 0-2; 5. Expected survival = 12 weeks; 6. Adequate bone marrow, liver, and kidney function; 7. Female patients of childbearing potential who voluntarily use effective contraception during the study period and for 6 months after the last study medication, such as double barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc.
Exclusion criteria
Exclusion criteria: 1. Having had other malignant tumors within the past 5 years (excluding basal cell carcinoma or squamous cell carcinoma of the skin that has been cured, and cervical carcinoma in situ); 2. Having undergone major surgery within 4 weeks prior to enrollment (the definition of major surgery refers to level 3 and 4 surgeries as stipulated in the "Administrative Measures for Clinical Application of Medical Technologies" implemented on May 1, 2009) or having an unhealed wound or fracture that is clinically significant as assessed by the investigator; 1.or being expected to undergo major surgery during the study (excluding surgery for diagnostic purposes); 2.for stoma formation, the fistula must have been stable for 4 weeks. 3. Uncontrollable malignant pleural effusion, ascites, or pericardial effusion (defined as not being effectively controlled by diuretics or puncture, as determined by the investigator); 4. The patient currently has any disease or condition that affects drug absorption, or the patient cannot take the medication orally; 5. The patient currently has active gastrointestinal ulcers, large or deep ulcers, ulcerative colitis, or other gastrointestinal diseases or unresected tumors with active bleeding, or has severe gastrointestinal dysfunction (infection, obstruction, =1 grade diarrhea, etc.), or other conditions determined by the investigator that may cause gastrointestinal bleeding or perforation; 3.or has gastrointestinal perforation or gastrointestinal fistula that has not healed after surgical treatment; 6. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; 4.congestive heart failure, New York Heart Association (NYHA) class =2; 5.left ventricular ejection fraction (LVEF) <50%; 6.known history of aneurysm; 7. 8. The investigator believes that the patient is unsuitable to participate in this clinical study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) ;Disease Control Rate (DCR);Duration of Response (DoR) ; | — |
Countries
China
Contacts
Public ContactLiu Jie
Shanghai tenth People's Hospital
Outcome results
None listed