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

NCT06028672 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-06

No results posted yet for this study

Summary

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.

Conditions

  • Gestational Trophoblastic Neoplasia

Interventions

DRUG

Toripalimab

200mg q2w intravenous

DRUG

Actinomycin-D

1.25mg/m2，2mg max dose, q2w, intravenous

Sponsors & Collaborators

  • Obstetrics & Gynecology Hospital of Fudan University

    collaborator OTHER

  • Shengjing Hospital

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Gansu Provincial Maternal and Child Health Care Hospital

    collaborator OTHER

  • Dalian Maternity and Child Care Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Xiamen University

    collaborator OTHER

  • Sichuan Cancer Hospital and Research Institute

    collaborator OTHER

  • Shanghai Junshi Bioscience Co., Ltd.

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-12
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06028672 on ClinicalTrials.gov