Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06413992
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluzoparib — DRUG
    During 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 — DRUG
    During 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) — DRUG
    Paclitaxel (albumin-bound) for injection, 260 mg/m\^2 administered intravenously in 3-week cycles for 6 cycles.
  • Carboplatin injection — DRUG
    AUC=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 — DRUG
    AUC=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 — RADIATION
    Non-essential, decision to combine is made by the principal investigator based on the patient's condition.

Study Details

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.

Key Dates

Start date
May 10, 2024
Status verified
May 2024
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
117 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab with Fluzoparib as maintainance therapy
    The treatment period mainly includes: 1. Injection of Paclitaxel (Albumin-bound) at a dose of 260mg/m\^2 administered intravenously every 3 weeks as one treatment cycle, for 6 cycles. 2. Injection of Carboplatin (AUC=5) administered intravenously every 3 weeks as one treatment cycle, for 6 cycles. 3. Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle, for 6 cycles. 4. Radiation therapy: Not mandatory. Maintainance therapy period mainly includes: 1. Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle until disease progression, intolerable toxicity, death, or up to a maximum of 2 years. 2. Oral administration of Fluzoparib capsules at a dose of 150mg, once in the morning and once in the evening until disease progression, intolerable toxicity, death, or up to a maximum of 2 years.
  • Active Comparator: Camrelizumab without Fluzoparib as maintainance therapy
    Treatment period mainly include: 1. Injection of Paclitaxel (Albumin-bound) at a dose of 260mg/m\^2 administered intravenously every 3 weeks as one treatment cycle, for a total of 6 cycles. 2. Injection of Carboplatin (AUC=5) administered intravenously every 3 weeks as one treatment cycle, for a total of 6 cycles. 3. Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle, for a total of 6 cycles. 4. Radiation therapy: Not mandatory. Whether to combine radiation therapy is determined by the principal investigator based on the patient's condition. Radiation therapy includes external beam radiation and brachytherapy. Maintainance therapy period mainly includes: a) Injection of Camrelizumab at a dose of 200mg administered intravenously every 3 weeks as one treatment cycle until disease progression, intolerable toxicity, death, or up to a maximum of 2 years.

Primary Outcome Measure

Investigator-assessed progression-free survival (PFS) [ Time Frame: 12 months ]

Central Contacts

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