Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7
NCT ID: NCT06020755
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
17 participants
INTERVENTIONAL
2024-12-31
2025-08-31
Brief Summary
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* Whether toripalimab plus actinomycin-D as fist-line treatment can achieve a high complete response rate.
* 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.
Participants will receive toripalimab plus actinomycin-D. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment will be completed after 4 consolidation cycles.
Detailed Description
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Eligible Participants will receive toripalimab (200mg q2w intravenous) plus actinomycin-D (1.25mg/m2，2mg max dose, intravenous). After normalization of serum β-human chorionic gonadotropin (β-hCG) levels, patients will receive 4 cycles of consolidation treatment. Treatment will be continued until completion of treatment, disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint is complete remission rate (the proportion of patients achieving complete remission). Secondary endpoints include objective response rate (the proportion of patients achieving complete remission and partial remission), progression-free survival (time from the treatment initiation to disease progression or death, whichever comes first), disease control rate, duration of response, overall survival (time from the treatment initiation to the date of death or last follow-up), duration of response (time from the first evidence of response to disease progression or death, whichever comes first) safety, biomarker, ovarian function and quality of life.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Toripalimab Plus Actinomycin-D
Toripalimab 200mg intravenously(IV) every 2 weeks (Q2W) Actinomycin-D 1.25mg/m2，2mg max dos, intravenously(IV) every 2 weeks (Q2W)
Toripalimab
200mg q2w intravenous
Actinomycin-D
1.25mg/m2，2mg max dose, q2w, intravenous
Interventions
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Toripalimab
200mg q2w intravenous
Actinomycin-D
1.25mg/m2，2mg max dose, q2w, intravenous
Eligibility Criteria
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Inclusion Criteria
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.
2. Patients with a FIGO score of 7.
3. Signed informed consent.
4. No previous immunotherapy, chemotherapy, or radiotherapy.
5. Woman aged 18-60 years.
6. Expected survival ≥ 6 months.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days before first dose.
8. 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
2. Histologically confirmed primary choriocarcinoma.
3. Other malignancies in the past 3 years.
4. Prior systemic anti-cancer treatment, including chemotherapy and radiotherapy.
5. Live vaccines injected within 30 days before the first dose of study drug;
6. 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.
7. 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).
8. Known hypersensitivity or allergy to actinomycin-D, toripalimab or any of their excipients.
9. Any active autoimmune disease requiring systemic treatment during the past 2 years.
10. History or current status of non-infectious pneumonia requiring steroid treatment.
11. Receiving steroid hormones (prednisone dose \> 10mg/ day) or other immunosuppressants within 14 days before enrollment, excluding those on hormone replacement therapy.
12. Active infection that requires systemic treatment.
13. Human immunodeficiency virus infection or known acquired immunodeficiency syndrome, active hepatitis B, hepatitis C.
14. History of psychotropic drug abuse and are unable to withdraw the psychotropic drug, or have mental disorders.
15. 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.
16. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal drug therapy).
17. 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.
18. History of cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 3 months before enrolment.
19. 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.
20. A history of allogeneic stem cell transplantation or organ transplantation.
21. Other reasons as judged by the investigator.
18 Years
60 Years
FEMALE
No
Sponsors
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Obstetrics & Gynecology Hospital of Fudan University
OTHER
Shengjing Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Henan Cancer Hospital
OTHER_GOV
Gansu Provincial Maternal and Child Health Care Hospital
OTHER
Dalian Maternity and Child Care Hospital
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Shanghai Junshi Bioscience Co., Ltd.
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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xiang yang
Professor
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yang Xiang
Role: primary
Other Identifiers
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TA7-GTN-001
Identifier Type: -
Identifier Source: org_study_id