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 range18 Years – 75 Years
SexFEMALE
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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);
✕. 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;
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: up to 96 weeks
Trial details
NCT IDNCT05028504
SponsorSichuan Cancer Hospital and Research Institute
. 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.