A Clinical Study on the Efficacy and Safety of All-trans Retinoic Acid Combined With VAC Regimen in the Treatment of Intermediate-to-high-risk Rhabdomyosarcoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-60
SponsorFudan University

About this trial

This study is a prospective, multi-cohort, multi-center clinical trial targeting patients with intermediate-to-high-risk rhabdomyosarcoma who have not previously received systemic anti-tumor treatment. It aims to evaluate the efficacy and safety of all-trans retinoic acid combined with VAC chemotherapy.

Eligibility criteria

Qualifiers

Age ≥ 14 years old and ≤ 60 years old;

Histologically confirmed medium to high risk rhabdomyosarcoma (excluding pleomorphic rhabdomyosarcoma);

The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0-1;

Have not received any anti-tumor drug treatment in the past;

Disqualifiers

Previously received anti-tumor treatment other than surgery and radiation therapy for any malignant tumor;

Subjects who cannot accept or tolerate this chemotherapy regimen for various reasons;

Biopsy confirmed a patient with bone marrow infiltration;

Patients who have undergone major surgical procedures unrelated to medium to high risk rhabdomyosarcoma within the 4 weeks prior to enrollment, or who have not fully recovered from such surgical procedures;

Trial design

Treatments tested in this trial

  • ATRA+VAC
  • ATRA+VAC+Anlotinib

Treatment groups

106 Participants
are divided into 2 treatment groups

Sponsors and collaborators