Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6 — TA56  

Gestational Trophoblastic Neoplasia Clinical Trial

Official title: Efficacy and Safety of Actinomycin-D With or Without Toripalimab as Fist-Line Treatment in Patients With Gestational Trophoblastic Neoplasia With FIGO Score 5-6: A Multicenter, Open-label, Randomized Controlled Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The goal of this clinical trial is to evaluate the efficacy and safety of actinomycin-D with or without toripalimab as fist-line treatment in patients with gestational trophoblastic neoplasia with FIGO score 5-6.

Eligible Participants will be randomized into two groups. Those in experimental group will receive toripalimab (200mg q2w intravenous) plus actinomycin-D (1.25mg/m2，2mg max dose, intravenous). While those in control group will receive actinomycin-D (1.25mg/m2，2mg max dose, intravenous) alone. After normalization of serum β-human chorionic gonadotropin (β-hCG) levels, patients will receive 3 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. ;

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Gestational Trophoblastic Neoplasia
• Neoplasms

• NCT number: NCT06028672
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Completion date: August 2025