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Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7

NCT06020755 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-12-31

No results posted yet for this study

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.

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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-12-31
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 NCT06020755 on ClinicalTrials.gov