Actively Recruiting
Efficacy and Safety of Camrelizumab Plus Albumin-bound Paclitaxel/Carboplatin Followed by Camrelizumab With or Without Fluzoparib Maintenance Therapy for TP-53 Mutated Recurrent or Metastatic Endometrial Cancer: A Phase II Trial
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-05-14
117
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 mg/m2, 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 investigator’s 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.
CONDITIONS
Brief Title
Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 with expected survival of at least 6 months
- Newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) 2009 stage III-IV endometrial cancer or recurrent endometrial cancer after no more than one line of platinum-based chemotherapy
- For patients who failed platinum-based chemotherapy, a platinum-free interval of 12 months or more is required
- Confirmed TP53 gene mutation by sequencing methods and abnormal p53 expression
- No prior treatment with immune checkpoint blockers or poly (ADP-ribose) polymerase inhibitors (PARPi)
- At least 4 weeks since stopping previous radiation, chemotherapy, or hormone therapy
- Adequate organ function with specified blood and liver test limits
- Thyroid function within normal limits or controlled
- Peripheral neuropathy less than grade 2
- Signed informed consent and ability to provide tumor tissue samples for homologous recombination deficiency testing
- Willingness to comply with clinic visits and follow-up
You will not qualify if you...
- Participation in another clinical trial currently or within 4 weeks after completing one
- Allergy to any components of the study drugs
- Previous treatment with immune checkpoint inhibitors or PARP inhibitors
- Need for immunosuppressive medications or corticosteroids at immunosuppressive doses
- Active autoimmune diseases or history of autoimmune diseases excluding resolved asthma or vitiligo
- Active infections requiring antimicrobial treatment
- History of immunodeficiency including HIV
- Uncontrolled or significant heart conditions within the past year
- Recent arterial or venous thrombosis within 6 months
- Poorly controlled hypertension or significant proteinuria
- Blood clotting disorders or on blood thinners
- Other cancers within the past 5 years except certain skin cancers
- Live vaccine within 4 weeks before first study drug dose
- Substance abuse or psychiatric disorders affecting study participation
- Any other medical, psychiatric, or social conditions affecting safety or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Approximately 18 weeks (6 cycles of 3 weeks each)
Participants receive intravenous injections of Paclitaxel (albumin-bound), Carboplatin, and Camrelizumab every 3 weeks for 6 cycles. Radiation therapy may be added based on the investigator's decision.
Every 3 weeks for 6 visits (in-person)
Duration - Up to 2 years
Participants receive intravenous Camrelizumab every 3 weeks with or without oral Fluzoparib twice daily until disease progression, intolerable toxicity, death, or up to 2 years.
Every 3 weeks (in-person) for Camrelizumab and daily oral medication for Fluzoparib if assigned
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
S
Shuangzheng Jia, Ph D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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