OncoMatch/Clinical Trials/NCT06413992
Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer
Is NCT06413992 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT06413992 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune checkpoint inhibitor, poly (ADP-ribose) polymerase inhibitor disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 abnormal expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages