Efficacy and Safety of Toripalimab Plus Actinomycin-D As Fist-Line Treatment in Patients with Gestational Trophoblastic Neoplasia with FIGO Score 7: a Single-Arm, Multicenter, Phase II Trial
Overview
- Phase
- Phase 2
- Intervention
- Toripalimab
- Conditions
- Gestational Trophoblastic Neoplasia
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Complete remission rate
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
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. Eligible Participants will receive toripalimab (200mg q2w intravenous) plus actinomycin-D (1.25mg/m2，2mg max dose, intravenous). After normalization of serum β-human chorionic gonadotropin (β-hCG) levels, patients will receive 4 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.
Investigators
xiang yang
Professor
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- •Diagnosed as GTN:
- •There is a histologic diagnosis of choriocarcinoma or invasive mole. Postmolar GTN: The plateau of β-hCG (±10%) lasts for four measurements over a period of 3 weeks or longer (days 1, 7, 14, 21). There is a rise (\>10%) in β-hCG for three consecutive weekly measurements over at least a period of 2 weeks or more (days 1, 7, 14).
- •GTN after nonmolar pregnancy: There is a rise after decease, or a plateau of β-hCG 4 weeks after abortion, ectopic pregnancy, or term delivery. Pregnancy residue or new pregnancy have been ruled out.
- •Patients with a FIGO score of
- •Signed informed consent.
- •No previous immunotherapy, chemotherapy, or radiotherapy.
- •Woman aged 18-60 years.
- •Expected survival ≥ 6 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days before first dose.
- •The function of vital organs meets the following requirements:
Exclusion Criteria
- •Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT).
- •Histologically confirmed primary choriocarcinoma.
- •Other malignancies in the past 3 years.
- •Prior systemic anti-cancer treatment, including chemotherapy and radiotherapy.
- •Live vaccines injected within 30 days before the first dose of study drug;
- •Systemic immune stimulant agent (such as a bacterial or viral vaccine, colony-stimulating factors, interferon, interleukin, and combined vaccine) was used 6 weeks before administration or within the 5 half-lives of the drug, whichever is shorter.
- •Previous treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, PD-L2, cytotoxic T-lymphocyte-associated protein 4, T-cell receptor, chimeric antigen receptor T-cell therapy, and other immunotherapy).
- •Known hypersensitivity or allergy to actinomycin-D, toripalimab or any of their excipients.
- •Any active autoimmune disease requiring systemic treatment during the past 2 years.
- •History or current status of non-infectious pneumonia requiring steroid treatment.
Arms & Interventions
Toripalimab Plus Actinomycin-D
Toripalimab 200mg intravenously(IV) every 2 weeks (Q2W) Actinomycin-D 1.25mg/m2，2mg max dos, intravenously(IV) every 2 weeks (Q2W)
Intervention: Toripalimab
Toripalimab Plus Actinomycin-D
Toripalimab 200mg intravenously(IV) every 2 weeks (Q2W) Actinomycin-D 1.25mg/m2，2mg max dos, intravenously(IV) every 2 weeks (Q2W)
Intervention: Actinomycin-D
Outcomes
Primary Outcomes
Complete remission rate
Time Frame: up to one year
The proportion of patients achieving complete remission. Complete remission is defined as normal serum β-hCG level measured for 4 consecutive weeks.
Secondary Outcomes
- Reproductive concerns after cancer(up to one year)
- Overall survival(up to one year)
- Quality of life of cancer patients(up to one year)
- Objective response rate(up to one year)
- Progression-free survival(up to one year)
- Duration of response(up to one year)
- Treatment-Emergent Adverse Events [Safety and Tolerability](up to one year)
- Cancer specific rehabilitation(up to one year)
- Ovarian function(up to one year)
- Disease control rate(up to one year)