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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Fluzoparib
DrugDuring the maintenance phase of treatment. Oral administration of Fluzoparib capsules at a dose of 150mg（N=78 participants）, once in the morning and once in the evening until disease progression, intolerable toxicity, death, or up to a maximum of 2 years.
Camrelizumab
DrugDuring the maintenance phase of treatment. Camrelizumab, 200 mg administered intravenously every 3 weeks until disease progression, intolerable toxicity, death, or up to 2 years.
paclitaxel (albumin bound)
DrugPaclitaxel (albumin-bound) for injection, 260 mg/m\^2 administered intravenously in 3-week cycles for 6 cycles.
Carboplatin injection
DrugAUC=5 Intravenous dosing is administered every 3 weeks for a total of 6 treatment cycles. Specific dosing cycles may be determined by the investigator
Carboplatin
DrugAUC=5 Intravenous dosing is administered every 3 weeks for a total of 6 treatment cycles. Specific dosing cycles may be determined by the investigator
External irradiation
RadiationNon-essential, decision to combine is made by the principal investigator based on the patient's condition.
Treatment groups
117 Participants
are divided into 2 treatment groupsGroup A: Camrelizumab with Fluzoparib as maintainance therapyExperimental treatment 6 interventions
Group B: Camrelizumab without Fluzoparib as maintainance therapyActive comparator 5 interventions
Trial outcomes
Primary outcomes
1
Investigator-assessed progression-free survival (PFS)
The time between randomization and tumor progression or death
Time frame
12 monthsSecondary outcomes
1
Duration of Response（DoR）
The duration of remission or complete disappearance of the patient's disease after treatment
Time frame
12 months2
Overall Survival(OS)
The time between randomization and death.
Time frame
24 monthsOther outcomes
1
Effect of HRD status and HRR-mutated on PFS
PFS in patients with different (Homologous Recombination Deficiency)HRD status and (Homologous Recombination Repair)HRR mutations
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov