Gestational Trophoblastic Neoplasia
Conditions
Interventions
Single arm:TP/TE (Paclitaxel, Cisplatin/Paclitaxel, Etoposide) (Repeat every 2 weeks)+ QL1706(Ipilimumab and Tovoritelimab) (Repeat every 3 weeks)
Paclitaxel 135 mg/m2 IV over 3 hours on Day 1
Cisp
Sponsors
The Obstetrics & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be enrolled in this study 1)Patients voluntarily agree to participate in this study and sign the informed consent form; Meet the diagnostic criteria for Gestational Trophoblastic Neoplasia (GTN) according to the 2021 FIGO Cancer Report, and meet any one of the following two conditions: ?(1) Relapsed GTN after at least one combined chemotherapy regimen:?? Previous history of GTN treated to achieve complete remission (including at least one combined chemotherapy regimen), with an increase in serum hCG levels detected consecutively twice (with an interval of at least one week), excluding pregnancy and other causes of elevated serum hCG. ?(2) Chemoresistant GTN (>= 1 combined regimen):?? Chemoresistance is defined as failure (serum hCG level decrease = 3.5 × 10^9/L (2). Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L (3). Platelets >= 100 × 10^9/L (4). Hemoglobin >= 9.0 g/dL [a] (5). Serum Creatinine 1.5 × ULN) (7). Aspartate Aminotransferase (AST/SGOT) or Alanine Aminotransferase (ALT/SGPT) <= 2.5 × ULN (8). International Normalized Ratio (INR) or Prothrombin Time (PT), and Activated Partial Thromboplastin Time (aPTT) <= 1.5 × ULN (if a subject is receiving anticoagulant therapy, the PT or PTT must be within the therapeutic range intended for the anticoagulant). a. Must have met the criteria for the past 2 weeks and not be dependent on erythropoietin; Transfusion with packed red blood cells (RBCs) is allowed prior to enrollment. b. Creatinine clearance (CrCl) should be calculated according to institutional standards. ?Note:?? ALT (SGPT) = Alanine Aminotransferase (Serum Glutamic-Pyruvic Transaminase); AST (SGOT) = Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase); GFR = Glomerular Filtration Rate; ULN = Upper Limit of Normal.
Exclusion criteria
Exclusion criteria: 1) Diagnosis of non-gestational choriocarcinoma.?? ??(2) Comorbidities: Concurrent malignancy undergoing treatment (excluding malignancies cured >= 3 years ago).?? ??(3) Prior/Concomitant Therapies? 1) Received or scheduled to receive a live vaccine within 30 days prior to the first dose of study treatment. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccine. Injectable seasonal influenza vaccines are generally inactivated viral vaccines and are permitted; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. 2) Treatment with systemic immunostimulatory agents (such as bacterial or viral vaccines, interferons, interleukins, and combination vaccines), within 6 weeks prior to Day 1 of Cycle 1 or within 5 half-lives of the agent (whichever is shorter). Exception: Use of granulocyte colony-stimulating factor (G-CSF) during prior chemotherapy is permitted. 3) History of severe hypersensitivity to PD-1 antibody or chemotherapy drugs. 4) Active autoimmune disease requiring systemic treatment (e.g., with disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Exceptions: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment and is permitted. 5) History of (non-infectious) pneumonitis requiring steroids or current (non-infectious) pneumonitis. 6) Active infection requiring systemic therapy. 7) Known history of HIV infection. Known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus infection (defined as detectable HCV RNA [qualitative]). 8) History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that may increase the risk associated with study participation or administration of study intervention, or may interfere with the interpretation of study results, and that, in the investigator's judgment, makes the subject unsuitable for enrollment in this study. 9) Known psychiatric or substance abuse disorder that may interfere with the subject's ability to cooperate with study requirements. 10) >= Grade 2 myocardial ischemia or myocardial infarction, or poorly controlled cardiac arrhythmias (including QTc interval >= 450 msec for males or >= 470 msec for females). NYHA Class III or IV cardiac insufficiency; or left ventricular ejection fraction (LVEF) = 140 mmHg or diastolic BP >= 90 mmHg despite optimal medical therapy). 13) Coagulopathy (INR >1.5 or PT > ULN + 4 seconds or aPTT >1.5 × ULN), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy. 14) Urinalysis indicating urine protein >= ++ or confirmed 24-hour urine protein >= 1.0 g. ??(4) Others: Any condition that, in the investigator's judgment, may
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-Free-Survival;Complete regression rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrent Rate;Resistant Rate;Safety; | — |
Countries
China
Contacts
Public ContactLu xin
The Obstetrics & Gynecology Hospital of Fudan University
Outcome results
None listed