A Phase II Study of Anlotinib Combined With Penpulimab in Subjects With Gynecological Cancer (NCT05028504) | Clinical Trial Compass
UnknownPhase 2
A Phase II Study of Anlotinib Combined With Penpulimab in Subjects With Gynecological Cancer
China86 participantsStarted 2022-05-10
Plain-language summary
This is a single-arm, open-label, phase II clinical trial to evaluate the efficacy and safety of penpulimab combined with anlotinib in subjects with gynecological cancer, including 23 ovarian cancer，37 endometrial cancer，26 cervical cancer.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Platinum-resistant relapsed or platinum-refractory ovarian cancer, the patient has received at least 1 line of platinum-based chemotherapy after previous cytoreductive surgery;
. With residual disease after surgery or inoperable stage III-IV endometrial cancer, and refused to receive chemoradiation/radiation/chemotherapy; or recurrent endometrial cancer unsuitable or refusing standard therapy;
. Persistent cervical cancer unsuitable for curative treatment, or recurrent/metastatic cervical cancer that refuses to receive standard treatment (for recurrent disease, not yet treated).
. Blood routine inspection: Hemoglobin (HB) \>= 90 g/L; The absolute value of neutrophil (ANC) \>= 1.5x10\^9/L;Platelets (PLT) \>= 100x10\^9/L;
. Blood biochemical inspection: Serum creatinine (Cr) \<= 1.5 ULN, or creatinine clearance (CCr) \>= 60mL / min; Total bilirubin (TBIL) \<= 1.5 ULN, or direct bilirubin \<= 1.0 ULN; AST and ALT \<= 2.5 ULN.
. Blood coagulation function: Activated partial thromboplastin time, international standardized ratio adn prothrombin time \<=1.5 ULN;
. Cardiac Function: left ventricular ejection fraction (LVEF) \>=50%;
Exclusion criteria
. Blood pressure control is not ideal (systolic pressure \>= 150 mmHg, diastolic pressure \>= 100 mmHg);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: up to 96 weeks
Trial details
NCT IDNCT05028504
SponsorSichuan Cancer Hospital and Research Institute
. Patients had Unstable angina pectoris, myocardial infarction, ≥grade 2 congestive heart failure, or arrhythmia requiring treatment (including QTc ≥480 ms) within 6 months before enrollment;
. Active or uncontrolled serious infection (≥CTC AE grade 2 infection);
. Epidemiological test results during the screening period showed that any of the following is met: \* HBsAg positive and HBV DNA exceeds the upper limit of normal value (those who fall within the normal range after antiviral treatment can be included); \* Anti-HCV positive and HCV RNA positive; \* HIV positive;
. Had an arterio / venous thrombotic / carcinothrombotic event within 6 months, such as cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, and Hypertensive crisis or hypertensive encephalopathy;
. Exacerbated chronic obstructive pulmonary disease (COPD) or other respiratory diseases that require hospitalization, or have active lung infections and/or acute bacterial or fungal infections that require intravenous antibiotic treatment within 28 days before the first dose.