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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06020755
Other study ID # TA7-GTN-001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 2023
Est. completion date August 2025

Study information

Verified date September 2023
Source Peking Union Medical College Hospital
Contact Yang Xiang
Phone +861069156068
Email xiangy@pumch.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab plus actinomycin-D as fist-line treatment in patients with gestational trophoblastic neoplasia with FIGO score 7. The main questions it aims to answer are: - 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.


Description:

The goal of this clinical trial is to evaluate the efficacy and safety of toripalimab plus actinomycin-D as fist-line treatment in patients with gestational trophoblastic neoplasia with FIGO score 7. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 17
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. Diagnosed as GTN: There is a histologic diagnosis of choriocarcinoma or invasive mole. Postmolar GTN: The plateau of ß-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 ß-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 ß-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: 1. Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT). 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.

Study Design


Related Conditions & MeSH terms

  • Gestational Trophoblastic Disease
  • Gestational Trophoblastic Neoplasia
  • Neoplasms

Intervention

Drug:
Toripalimab
200mg q2w intravenous
Actinomycin-D
1.25mg/m2,2mg max dose, q2w, intravenous

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (10)

Lead Sponsor Collaborator
Peking Union Medical College Hospital Dalian Maternity and Child Care Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Henan Cancer Hospital, Obstetrics & Gynecology Hospital of Fudan University, Shanghai Junshi Bioscience Co., Ltd., Shengjing Hospital, Sichuan Cancer Hospital & Institute, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete remission rate The proportion of patients achieving complete remission. Complete remission is defined as normal serum ß-hCG level measured for 4 consecutive weeks. up to one year
Secondary Objective response rate The proportion of patients with complete or partial response according to serum ß-hCG level. up to one year
Secondary Progression-free survival The time from the treatment initiation to disease progression or death, whichever comes first. Disease progression is defined as any increase in serum ß-hCG level from baseline after 2 cycles of treatment or the presence of new metastatic lesions. up to one year
Secondary Disease control rate The proportion of patients with complete response, partial response, or stable disease according to serum ß-hCG level. up to one year
Secondary Duration of response The time from the first evidence of response to disease progression or death, whichever comes first. up to one year
Secondary Overall survival The time from the treatment initiation to the date of death or last follow-up. up to one year
Secondary Treatment-Emergent Adverse Events [Safety and Tolerability] Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 5.0) . up to one year
Secondary Ovarian function Determine ovarian function as assessed by anti-Müllerian hormone (AMH) up to one year
Secondary Quality of life of cancer patients Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30) up to one year
Secondary Cancer specific rehabilitation Assessed by Cancer rehabilitation evaluation system-short form (CARES-SF) up to one year
Secondary Reproductive concerns after cancer Assessed by Reproductive Concerns After Cancer (RCAC) scale up to one year
See also
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Terminated NCT02664961 - Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN) Phase 2
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Recruiting NCT05635344 - A Feasibility Window Study of Pembrolizumab Prior to Second Evacuation for Post-molar Gestational Trophoblastic Neoplasia Phase 2
Recruiting NCT04756713 - Second Uterine Evacuation for Low-risk Gestational Trophoblastic Neoplasia Phase 3
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Active, not recruiting NCT01823315 - Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia Phase 3
Not yet recruiting NCT06169644 - The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment
Recruiting NCT04812002 - Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy Phase 2