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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.

Phase 2RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT06413992Data as of May 2026

Treatment: Fluzoparib · Camrelizumab · paclitaxel (albumin bound) · Carboplatin · CarboplatinThis 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.

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Extracted 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

Max 1 prior line

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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