OncoMatch/Clinical Trials/NCT06413992
Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer
Is NCT06413992 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for endometrial carcinoma.
Treatment: Fluzoparib · Camrelizumab · paclitaxel (albumin bound) · Carboplatin · Carboplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: TP53 mutation
confirmation of TP53 gene mutation by Sanger sequencing or next-generation sequencing (NGS)
Required: TP53 abnormal expression
abnormal p53 expression indicated by immunohistochemistry
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — neoadjuvant, adjuvant, or concurrent
after ≤ 1 line of platinum-based chemotherapy (including neoadjuvant, adjuvant, and concurrent chemotherapy)
Cannot have received: immune checkpoint inhibitor
No prior treatment with immune checkpoint blockade (ICB)
Cannot have received: poly (ADP-ribose) polymerase inhibitor
No prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi)
Lab requirements
Blood counts
platelets ≥ 90,000 cells/mm3, hemoglobin ≥ 90 g/L, neutrophils ≥ 1,500/mm3
Kidney function
serum creatinine ≤ 1.5x ULN
Liver function
AST and ALT ≤ 2.5x ULN (≤ 5x for patients with liver metastasis); total bilirubin ≤ 1.5x ULN
Adequate organ function as follows (no use of drugs containing blood components or corrective treatment with hematopoietic growth factors in the 7 days prior to randomization): Aspartate Aminotransferase (AST) and Alanine Transaminase (ALT) ≤ 2.5 times the upper limit of normal (≤ 5 times for patients with liver metastasis) and total bilirubin ≤ 1.5 times the upper limit of normal; serum creatinine ≤ 1.5 times the upper limit of normal; platelets ≥ 90,000 cells/mm3, hemoglobin ≥ 90 g/L, and neutrophils ≥ 1,500/mm3.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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