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New treatment option for Gestational Trophoblastic Neoplasia
Official title Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6
ClinicalTrials.gov ID: NCT06028672
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gestational trophoblastic neoplasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Whether toripalimab plus actinomycin-D as fist-line treatment can achieve a higher complete response rate than actinomycin-D alone. Whether an equally high cure rate can be achieved by multi-drug chemotherapy as second-line treatment in patients who have failed fist-line treatment with toripalimab plus actinomycin-D.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- Diagnosed as GTN: There is a histologic diagnosis of choriocarcinoma or invasive mole. Postmolar GTN: The plateau of β-hCG (±10%) lasts for four...
- Patients with a FIGO score of 5-6. Signed informed consent. No previous immunotherapy, chemotherapy, or radiotherapy. Woman aged 18-60 years...
- The function of vital organs meets the following requirements: hemoglobin ≥90 g/L, absolute neutrophil count ≥1 5×109/L, platelets ≥100×109/L...
You likely can't join if
- Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT).
- Histologically confirmed primary choriocarcinoma. Other malignancies in the past 3 years. Prior systemic anti-cancer treatment, including...
- Previous treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, PD-L2, cytotoxic T-lymphocyte-associated protein 4, T-cell...
- Known hypersensitivity or allergy to actinomycin-D, toripalimab or any of their excipients.
- Any active autoimmune disease requiring systemic treatment during the past 2 years.
- History or current status of non-infectious pneumonia requiring steroid treatment.
See the full eligibility criteria
- Diagnosed as GTN: There is a histologic diagnosis of choriocarcinoma or invasive mole. Postmolar GTN: The plateau of β-hCG (±10%) lasts for four measurements over a period of 3 weeks or longer (days 1, 7, 14, 21). There...
- Patients with a FIGO score of 5-6. Signed informed consent. No previous immunotherapy, chemotherapy, or radiotherapy. Woman aged 18-60 years. Expected survival ≥ 6 months. Eastern Cooperative Oncology Group (ECOG)...
- The function of vital organs meets the following requirements: hemoglobin ≥90 g/L, absolute neutrophil count ≥1 5×109/L, platelets ≥100×109/L; creatinine ≤1 5 × upper limit of normal (ULN), urea nitrogen ≤2 5×ULN; total...
- Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT).
- Histologically confirmed primary choriocarcinoma. Other malignancies in the past 3 years. Prior systemic anti-cancer treatment, including chemotherapy and radiotherapy. Live vaccines injected within 30 days before the...
- Previous treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, PD-L2, cytotoxic T-lymphocyte-associated protein 4, T-cell receptor, chimeric antigen receptor T-cell therapy, and other...
- Known hypersensitivity or allergy to actinomycin-D, toripalimab or any of their excipients.
- Any active autoimmune disease requiring systemic treatment during the past 2 years.
- History or current status of non-infectious pneumonia requiring steroid treatment.
- Receiving steroid hormones (prednisone dose \> 10mg/ day) or other immunosuppressants within 14 days before enrollment, excluding those on hormone replacement therapy.
- Active infection that requires systemic treatment. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome, active hepatitis B, hepatitis C.
- History of psychotropic drug abuse and are unable to withdraw the psychotropic drug, or have mental disorders.
- Grade II or higher myocardial ischemia, myocardial infarction or poorly controlled arrhythmia (females with QTc interval ≥470 ms); grade III to IV cardiac insufficiency according to New York Heart Association (NYHA)...
- Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal drug therapy).
- Abnormal coagulation (international normalized ratio \>1 5×ULN or prothrombin time \>ULN+4 seconds or activated partial thromboplastin time \>1 5×ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant...
- History of cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 3 months before enrolment.
- Obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction, or sinus or perforation of empty organs within 6 months.
- A history of allogeneic stem cell transplantation or organ transplantation. Other reasons as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.