Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorPeking Union Medical College Hospital

About this trial

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.

Participants will be allocated into two groups. Those in experimental group will receive toripalimab plus actinomycin-D, while those in control group will receive actinomycin-D alone. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment will be completed after 3 consolidation cycles.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Toripalimab
  • Actinomycin-D

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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