Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Gestational Trophoblastic Disease

Trophoblastic Neoplasms

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Pregnancy Complications

Pregnancy Complications, Neoplastic

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Gestational Trophoblastic Tumor

Vasodilator Agents

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Nitroglycerin

Dactinomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Toripalimab 200mg intravenously(IV) every 2 weeks (Q2W) Actinomycin-D 1.25mg/m2，2mg max dos, intravenously(IV) every 2 weeks (Q2W)

Actinomycin-D 1.25mg/m2，2mg max dos, intravenously(IV) every 2 weeks (Q2W)

Toripalimab

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

Actinomycin-D

Yang Xiang

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.

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.

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

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

The proportion of patients achieving complete remission. Complete remission is defined as normal serum β-hCG level measured for 4 consecutive weeks.

The proportion of patients with complete or partial response according to serum β-hCG level.

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.

The proportion of patients with complete response, partial response, or stable disease according to serum β-hCG level.

The time from the first evidence of response to disease progression or death, whichever comes first.

The time from the treatment initiation to the date of death or last follow-up.

Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 5.0) .

Ovarian function as assessed by anti-Müllerian hormone (AMH)

Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)

Assessed by Cancer rehabilitation evaluation system-short form (CARES-SF)

Assessed by Reproductive Concerns After Cancer (RCAC) scale. The minimum and maximum values are 18 and 90 respectively, and a higher score means a higher level of reproductive concern or anxiety

Spots Global Cancer Trial Database for international federation of gynecology and obstetrics