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Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer

NCT06413992 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-05-14

No results posted yet for this study

Summary

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

  • Endometrial Carcinoma
  • TP53 Mutation
  • Recurrent or Metastatic

Interventions

DRUG

Fluzoparib

During the maintenance phase of treatment. Oral administration of Fluzoparib capsules at a dose of 150mg（N=78 participants）, once in the morning and once in the evening until disease progression, intolerable toxicity, death, or up to a maximum of 2 years.

DRUG

Camrelizumab

During the maintenance phase of treatment. Camrelizumab, 200 mg administered intravenously every 3 weeks until disease progression, intolerable toxicity, death, or up to 2 years.

DRUG

paclitaxel (albumin bound)

Paclitaxel (albumin-bound) for injection, 260 mg/m\^2 administered intravenously in 3-week cycles for 6 cycles.

DRUG

Carboplatin injection

AUC=5 Intravenous dosing is administered every 3 weeks for a total of 6 treatment cycles. Specific dosing cycles may be determined by the investigator

DRUG

Carboplatin

AUC=5 Intravenous dosing is administered every 3 weeks for a total of 6 treatment cycles. Specific dosing cycles may be determined by the investigator

RADIATION

External irradiation

Non-essential, decision to combine is made by the principal investigator based on the patient's condition.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • GUANGWEN YUAN, MD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2026-06-01
Completion
2027-06-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06413992 on ClinicalTrials.gov