Actively Recruiting
Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-05-14
117
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 FIGO 2009 stage III-IV endometrial cancer or recurrent endometrial cancer after 1 or fewer lines of platinum-based chemotherapy
- Platinum-free interval of 12 months or more if previously treated with platinum-based chemotherapy
- Confirmed TP53 gene mutation by Sanger sequencing or next-generation sequencing, with no restriction on pathological type
- No prior treatment with immune checkpoint blockade (ICB) or poly (ADP-ribose) polymerase inhibitors (PARPi)
- At least 4 weeks since last radiation therapy, chemotherapy, or hormone therapy
- Adequate organ function with specific laboratory value limits for liver enzymes, bilirubin, creatinine, platelets, hemoglobin, and neutrophils
- Thyroid-stimulating hormone (TSH) level within normal limits or free T4 within normal limits if TSH abnormal
- Peripheral neuropathy grade less than 2 before treatment
- 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 prior
- Known allergy to any components of the investigational drug
- Previous treatment with immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 antibodies
- Requirement for immunosuppressive medications
- Previous treatment with poly (ADP-ribose) polymerase inhibitors (PARPi)
- Use of systemic or absorbable topical corticosteroids at immunosuppressive doses or prednisone >10 mg/day within 2 weeks before study drug
- Active autoimmune disease or history of autoimmune diseases (excluding resolved childhood asthma/atopic diseases and vitiligo)
- Active infectious diseases requiring antimicrobial treatment
- History of immunodeficiency including HIV infection
- Uncontrolled significant cardiac diseases or symptoms within the past year
- Arterial or venous thrombosis within the past 6 months
- Poorly controlled hypertension despite medication
- Coagulation abnormalities or bleeding tendencies
- Other malignant tumors within the past 5 years except certain skin cancers
- Live vaccine administration within 4 weeks prior to first investigational drug dose
- History of substance abuse or psychiatric disorders impacting study participation
- Any other medical, psychiatric, or social factors affecting safety or ability to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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