Combination treatment of toripalimab and actinomycin-D for gestational trophoblastic neoplasia
Efficacy and Safety of Actinomycin-D With or Without Toripalimab as Fist-Line Treatment in Patients With Gestational Trophoblastic Neoplasia With FIGO Score 5-6: A Multicenter, Open-label, Randomized Controlled Trial
This study is testing if combining two drugs, toripalimab and actinomycin-D, can help people with gestational trophoblastic neoplasia respond better than just using actinomycin-D alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | toripalimab, chimeric antigen receptor, chemotherapy, immunotherapy, prednisone |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06028672 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of combining toripalimab with actinomycin-D as a first-line treatment for patients diagnosed with gestational trophoblastic neoplasia (GTN) with a FIGO score of 5-6. Participants will be randomly assigned to receive either the combination treatment or actinomycin-D alone. The primary goal is to determine if the combination therapy achieves a higher complete response rate compared to the control group. Secondary endpoints include various measures of treatment response, progression-free survival, and overall survival. The treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-60 years with a confirmed diagnosis of GTN and a FIGO score of 5-6.
Not a fit: Patients who have previously undergone immunotherapy, chemotherapy, or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the complete response rates for patients with gestational trophoblastic neoplasia.
How similar studies have performed: While this approach is novel in the context of GTN, similar combination therapies have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 is a rise (\>10%) in β-hCG for three consecutive weekly measurements over at least a period of 2 weeks or more (days 1, 7, 14). GTN after nonmolar pregnancy: There is a rise after decease, or a plateau of β-hCG 4 weeks after abortion, ectopic pregnancy, or term delivery. Pregnancy residue or new pregnancy have been ruled out. 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) performance status of 0-2 within 7 days before first dose. 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 bilirubin ≤1.5×ULN, alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN, INR, PT or APTT ≤1.5×ULN, thyroid stimulating hormone ≤ULN (if thyroid stimulating hormone is abnormal, normal T3 and T4 can also be acceptable). Exclusion Criteria: 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 first dose of study drug; Systemic immune stimulant agent (such as a bacterial or viral vaccine, colony-stimulating factors, interferon, interleukin, and combined vaccine) was used 6 weeks before administration or within the 5 half-lives of the drug, whichever is shorter. 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 immunotherapy). 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) criteria, or cardiac color Doppler ultrasound evidence of left ventricular ejection fraction \<50%; myocardial infarction, NYHA grade II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or abnormal active conduction system occurring within 6 months before enrolment. 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 therapy. 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.