Phase II Study of Camrelizumab Combined with Albumin-bound Paclitaxel and Carboplatin Followed by Camrelizumab With or Without Fluzoparib Maintenance in Women With TP-53 Mutated Recurrent or Metastatic Endometrial Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining camrelizumab with fluzoparib as maintenance therapy in patients with recurrent or metastatic TP-53 mutated endometrial cancer. This open-label Phase II randomized controlled trial involves 117 participants and aims to explore how common homologous recombination deficiency is in Chinese patients with this mutation and its impact on treatment outcomes. The study addresses the need to optimize treatment strategies for this specific patient group due to mixed results from previous trials involving chemotherapy and immunotherapy combinations. Participants receive an initial treatment period including intravenous injections of paclitaxel albumin-bound at 260 mgm2, carboplatin at an AUC of 5, and camrelizumab at 200 mg every three weeks for six cycles. Radiation therapy may be given based on the investigators decision. Following this, patients enter a maintenance phase where camrelizumab is administered intravenously every three weeks, with or without oral fluzoparib capsules taken twice daily, continuing until disease progression, intolerable side effects, death, or up to two years. During the study, participants undergo regular assessments to monitor their health and treatment response, including evaluation of progression-free survival at 12 months, duration of response, and overall survival up to 24 months. The trial requires participants to comply with clinic visits and follow-up schedules. Researchers also collect tumor tissue samples to test for homologous recombination deficiency. Safety is closely monitored throughout the treatment and maintenance phases to ensure participant well-being.

Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer