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.
Patients with a FIGO score of 7.
Signed informed consent.
No previous immunotherapy, chemotherapy, or radiotherapy.
Woman aged 18-60 years.
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.
Single group
Toripalimab
Drug200mg q2w intravenous
Actinomycin-D
Drug1.25mg/m2，2mg max dose, q2w, intravenous
Complete remission rate
The proportion of patients achieving complete remission. Complete remission is defined as normal serum β-hCG level measured for 4 consecutive weeks.
Objective response rate
The proportion of patients with complete or partial response according to serum β-hCG level.
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 β-hCG level from baseline after 2 cycles of treatment or the presence of new metastatic lesions.
Disease control rate
The proportion of patients with complete response, partial response, or stable disease according to serum β-hCG level.
Duration of response
The time from the first evidence of response to disease progression or death, whichever comes first.
Click on the lead sponsor to view all of their trials.
Peking Union Medical College Hospital
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Shengjing Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Henan Cancer Hospital
Collaborator
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator
Dalian Maternity and Child Care Hospital
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Shanghai Junshi Bioscience Co., Ltd.
Collaborator
