Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
This study is an open-label Phase II randomized controlled trial designed to evaluate the safety and efficacy of camrelizumab plus fluzoparib maintenance therapy in patients with recurrent or metastatic TP-53 mutated Endometrial Cancer. The study will also explore the prevalence of homologous recombination reficiency in Chinese patients with TP-53 mutated endometrial cancer and its therapeutic significance.
Eligibility criteria
Qualifiers
Age ≥18
Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG): 0-2. Expected survival ≥ 6 months.
Patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) 2009 stage III-IV endometrial cancer or recurrent endometrial cancer after ≤ 1 line of platinum-based chemotherapy (including neoadjuvant, adjuvant, and concurrent chemotherapy). For patients who have failed platinum-based chemotherapy, a platinum-free interval of ≥ 12 months is required.
No restriction on pathological type, abnormal p53 expression indicated by immunohistochemistry, and confirmation of TP53 gene mutation by Sanger sequencing or next-generation sequencing (NGS).
Disqualifiers
Currently participating in another clinical trial or within 4 weeks since completing another clinical trial.
Known allergy to any components of the investigational drug.
Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies.
Patients requiring the use of immunosuppressive medications.
Trial design
Treatments tested in this trial
- Fluzoparib
- Camrelizumab
- paclitaxel (albumin bound)
- Carboplatin injection
- Carboplatin
- External irradiation
Treatment groups
117 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov